Methods and systems for performing a medical procedure

ABSTRACT

Method and system for treating a patient using a compressible, pressure-attenuating device. According to one embodiment, the system is used to treat urinary tract disorders and comprises an access device, a delivery device, a pressure-attenuating device, and a removal device. The access device may be used to create a passageway to an anatomical structure, such as the patient&#39;s bladder. The delivery device may be inserted through the passageway created by the access device and may be used to deliver the pressure-attenuating device to the anatomical structure. The removal device may be inserted through the passageway created by the access device and may be used to view the bladder and/or to capture, to deflate and to remove the pressure-attenuating device.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.14/671,880, filed Mar. 27, 2015, which is a continuation of U.S. patentapplication Ser. No. 14/262,617, filed Apr. 25, 2014, now U.S. Pat. No.8,992,412, which is a continuation of U.S. patent application Ser. No.13/843,621, filed Mar. 15, 2013, now U.S. Pat. No. 8,894,563, whichclaims priority to U.S. Provisional Pat. Appl. Nos. 61/682,184, filedAug. 10, 2012, and 61/769,719, filed Feb. 26, 2013. The entire contentsof all of the above applications are incorporated by reference hereinand made a part of this specification. Any and all applications forwhich foreign or domestic priority claim is identified in theApplication Data Sheet as filed with the present application are herebyincorporated.

BACKGROUND OF THE INVENTION Field of the Invention

The present invention relates to methods and systems for performingmedical procedures on anatomical structures of the body. Such medicalprocedures may involve, for example, attenuating transient pressurewaves in anatomical structures of the body, for example, by implanting acompressible pressure-attenuating device in an anatomical structure ofthe body that is subjected to such pressure waves.

Description of the Related Art

Pressure waves are known to propagate through incompressible fluids invarious anatomical structures of the body. These pressure waves may becaused by normally-occurring events within the body, such as a beatingheart, breathing in the lungs, peristalsis actions in the GI tract, andmovement of the muscles of the body. Alternatively, these pressure wavesmay be caused by sudden events, such as coughing, laughing, externaltrauma to the body, and movement of the body relative to gravity. As theelasticity of the surrounding tissues and organs, sometimes referred toas compliance, decreases, the propagation of these pressure wavesincreases. These pressure waves have many undesirable effects rangingfrom discomfort to stress on the organs and tissue to fluid leakage torenal failure to stroke to heart attack to blindness.

Urinary tract disorders, such as frequency, urgency, incontinence, andcystitis, are a widespread problem in the United States and throughoutthe world, affecting people of all ages, both physiologically andpsychologically. Urine is primarily composed of water and is a virtuallyincompressible fluid in the typical pressure ranges that are presentwithin the human bladder. The relationship between the maximum urethralpressure and the intravesical pressure for normal voiding of the bladderis well-defined. During normal voiding, relaxation of the urethra occursbefore the detrusor muscle contracts to cause the intravesical pressureto exceed the urethral pressure.

Intravesical pressure spikes often result from volumetric tissuedisplacement in response to gravity, muscular activity or rapidacceleration. The lack of compliance of the bladder and the urinecontained in the bladder with respect to events of high frequency, highintensity and short wavelength results in minimal fluidic pressureattenuation of the higher frequency pressure wave(s) and results in highintravesical pressures that are directly transmitted to the bladder neckand urethra, which may or may not cause detrusor contractions. Underthese conditions, the urethra may act as a volumetric pressure reliefmechanism, allowing a proportional volume of fluid to escape thebladder, thereby lowering the intravesical pressure to a tolerablelevel. The urethra has a maximum urethral pressure value, and when theintravesical pressure exceeds the maximum urethral pressure, fluid willescape the bladder. Under these conditions, nerve receptors in thebladder and/or bladder neck and/or trigone trigger a detrusorcontraction that may lead to matriculation (frequency) or may subsidewithout matriculation (urgency) or may lead to the intravesical pressureexceeding the maximum urethral pressure resulting in fluid escaping thebladder (stress incontinence).

For the vast majority of patients suffering from problems of urinarytract disorders, such as frequency, urgency, stress and urgeincontinence and cystitis, the cause and/or contributor to bladderdysfunction is a reduction of overall dynamic bladder compliance, asopposed to a reduction of steady-state bladder compliance. Thesepatients may often have bladders that are compliant in steady-stateconditions but that become non-dynamically compliant when subjected toexternal pressure events having a short duration of, for example, lessthan 5 seconds or, in some cases, less than 0.5 seconds. Reduction indynamic compliance of the bladder is often caused by aging, use,distention, childbirth and trauma. In addition, the anatomical structureof the bladder in relation to the diaphragm, stomach, and uterus (forwomen) causes external pressure to be exerted on the bladder duringphysical activities, such as talking, walking, laughing, sitting,moving, turning, and rolling over. For a patient suffering from stressincontinence due to lack of dynamic compliance in the bladder, when theintravesical pressure exceeds the maximum urethral pressure, leakageoccurs.

In light of the foregoing, a number of attempts have been made to combaturinary tract disorders. One such attempt involves the use of anindwelling catheter connected to a collection bag with a clamping deviceon the catheter. Indwelling catheters, however, have a number ofdrawbacks. For instance, there is an infection risk associated withindwelling catheters, which provide a direct passage for bacteria orother microorganisms into the bladder. Thus, indwelling catheters canonly be used for relatively short-term situations. In addition,indwelling catheters and associated collection bags are not cosmeticallyappealing to most patients.

An approach that has been taken to address urinary incontinence involvesthe use of prosthetic urethral valves. One known prosthetic urethralvalve utilizes an inflatable cuff that is inserted around the outside ofthe urethra. Prosthetic urethral valves also have numerousdisadvantages. One disadvantage of these valves is that they typicallyrequire surgery for installation, and some of these valves must beoperated externally and, therefore, are dependent on manualintervention.

The use of intra-urethral valves to address urinary tract disorders isalso known. Typical intra-urethral valves also generally require manualintervention. Another problem associated with typical intra-urethralvalves is that the valves may be displaced into the bladder or expelledfrom the urethra. There is also an infection risk associated with manysuch valves since they often extend into the meatus and/or have portionsof the device external to the urethra providing a passage formicroorganisms into the bladder.

Electrical stimulation therapy, including rectal, intra-vaginal, andexternal varieties, has been used to tone the muscles and to stimulatenerves supporting the bladder and urethra. However, this type of therapyrequires lengthy and numerous treatments, and any benefits derived fromthe therapy typically diminish when the treatments are stopped.

Current surgical incontinence procedures typically focus on theaugmentation of urethral flow resistance. Such surgical interventionstypically include bladder neck suspensions and bulk (collagen)injections. Although these procedures can be clinically effective withcertain patients, problems include widely variable clinical outcomes,relatively high costs to perform, and potential complications related tosurgery. Moreover, the effects of such surgical procedures may beshort-lived.

Drug therapy also exists for a number of urinary tract conditions,including overactive bladder. These drugs include oral medications(systemic) and drugs delivered directly into the bladder. Unfortunately,these drugs typically suffer from side effects, lack of efficacy andhigh morbidity. In particular, oral medications typically do not provideimmediate relief of symptoms and include side effects, such as dry mouthand constipation. Drugs delivered directly into the bladder oftenrequire continuous or intermittent catheterization for introduction ofthe therapeutic agents at the clinically appropriate time.

As can be appreciated, the treatment methods described above eitherfocus on the augmentation of urethral flow resistance, the temporarystoppage or absorption of all urethral flow, or the relaxing of thedetrusor muscles to minimize unwanted contractions. The disadvantagesand limitations of these treatment methods are numerous and include: anexcessively high level of patient interaction required to operate and/orto maintain the devices, especially for elderly patients and forphysically or mentally challenged patients; limited clinical efficacy;restricted urine outflow; patient discomfort and side effects; urethraland bladder infections related to the devices used; and relatively greatexpense as compared to non-clinical solutions (diapers, pads, etc.).

Accordingly, an alternative approach to those described above has beento implant a compressible, pressure-attenuating device in the bladder inorder to lower the intravesical pressure. This approach is disclosed,for example, in the following documents, all of which are incorporatedherein by reference: U.S. Pat. No. 6,682,473, Matsuura et al., issuedJan. 27, 2004; U.S. Pat. No. 7,074,178, Connors et al., issued Jul. 11,2006; and U.S. Patent Application Publication No. 2010/0222802,Gillespie, Jr. et al., published Sep. 2, 2010. According to one aspectof the foregoing approach, a compressible device is inserted, in acompacted state, into the bladder of a patient through the patient'surethra, and, then, once in the bladder, the compressible device isexpanded, for example, by inflation with atmospheric air. A deliverysystem may be used to deliver the compressible device through theurethra and into the bladder and also may be used to expand thecompressible device from its compacted state to its expanded state andto deploy the compressible device, once expanded, from the deliverysystem. If removal or replacement of the compressible device is desired,a removal system may be used to remove the compressible device from thebladder through the urethra.

Although the above-described implantable, compressible,pressure-attenuating device has had some success in treating urinarytract disorders, the present inventors have identified certain areas ofimprovement relating to the device, its introduction into a patient, itsexpansion and deployment within a patient, and its removal from apatient.

SUMMARY OF THE INVENTION

It is an object of the disclosure to provide a method and system forperforming a medical procedure on an anatomical structure of a body. Themedical procedure may be performed, for example, to attenuate transientpressure waves in the anatomical structure and may involve, for example,implanting a compressible pressure-attenuating device in the anatomicalstructure subject to such pressure waves. Such a method and system maybe used in, but is not limited to use in, treating urinary tractdisorders.

A system may comprise one or more of the following: an access device, atherapeutic or diagnostic object, a delivery device, and a removaldevice. The access device may be used to create a passageway to theanatomical structure, such as, for example, a trans-urethral passagewayto a patient's bladder. The therapeutic or diagnostic object may be aninflatable device and may be, for example, a pressure-attenuatingdevice. The delivery device may be used to deliver a therapeutic ordiagnostic object to the anatomical structure. Such an object may be,for example, a pressure-attenuating device, which may be delivered tothe anatomical structure in a compacted or deflated state and theninflated and released from the delivery device. The removal device maybe used to view the anatomical structure. In addition, where an objectdelivered to the anatomical structure is an inflatablepressure-attenuating device, the removal device may also be used tocapture, to deflate, and to remove the pressure-attenuating device fromthe anatomical structure.

In some embodiments, an access device can provide access to ananatomical structure within a patient. The access device can comprise anelongated sheath or cannula, the elongated sheath comprising a proximalend, a distal end, and a longitudinal channel. The access device mayalso include an obturator that can be removably mounted within thelongitudinal channel of the elongated sheath.

In some embodiments, an access device can comprise one or more of ahousing assembly, a sheath assembly, and a fluid control system. Thehousing assembly can comprise one or more housing structures that definea body for the access device.

According to one aspect, there is provided an access device for use inproviding access to an anatomical structure within a patient. The accessdevice can comprise (a) an elongated sheath, the elongated sheathcomprising a channel; (b) an obturator, the obturator being insertableinto the channel of the elongated sheath; and (c) a locking mechanismfor selectively locking the obturator within the channel of theelongated sheath.

According to another aspect, there is provided an access device for usein providing access to an anatomical structure within a patient. Theaccess device can comprise (a) an elongated sheath, the elongated sheathcomprising a sheath channel; (b) an obturator, the obturator beinginsertable into the sheath channel of the elongated sheath, theobturator comprising an obturator channel; and (c) an obturator handle,the obturator handle being secured to a proximal end of the obturator,the obturator handle comprising a handle channel, the handle channelbeing in fluid communication with the obturator channel.

In some embodiments, the access device can include a system forpositioning a flexible sleeve in an access channel. The flexible sleevecan be used to protect the access channel and/or body tissue in thepatient. For example, in some embodiments, the obturator can include acavity, and the sleeve can be positionable in the cavity in a firstposition and positionable outside of the cavity in a second position.The distal end of the obturator may also be positionable distally beyondthe distal end of an elongated sheath. In some embodiments, a slide ringcan be connected to the sleeve to move the sleeve between the first andsecond positions.

According to one aspect, there is provided an access device for use inproviding access to an anatomical structure within a patient. The accessdevice can comprise (a) an elongated sheath, the elongated sheathcomprising a proximal end, a distal end, and a longitudinal channel; (b)an obturator, the obturator being removably mounted within thelongitudinal channel of the elongated sheath, the obturator comprising aproximal end, a distal end, and a cavity, the distal end of theobturator being positionable distally beyond the distal end of theelongated sheath; (c) a slide ring, the slide ring being slidablymounted around the elongated sheath; and (d) a flexible sleeve, theflexible sleeve comprising a proximal end, a distal end, and alongitudinal channel, the proximal end of the flexible sleeve beingcoupled to the slide ring, the distal end of the flexible sleeve beingpositionable within the cavity of the obturator.

In some embodiments, the access device can include, in addition to theelongated sheath, a first fluid conduit, a second fluid conduit, and avalve mechanism for controlling fluid communication between the firstfluid conduit and the elongated sheath and between the second fluidconduit and the elongated sheath. The first fluid conduit may be used todeliver fluid to the elongated sheath for delivery to the patient, andthe second fluid conduit may be used to drain fluid from the patientthrough the elongated sheath. The valve mechanism may comprise a camwhich may be positioned in a first position in which the first fluidconduit is pinched shut by the cam and the second fluid conduit is keptopen, a second position in which the second fluid conduit is pinchedshut by the cam and the first fluid conduit is kept open, and a thirdposition in which both the first fluid conduit and the second fluidconduit are pinched shut by the cam. The cam may additionally bepositioned in a fourth position in which the first fluid conduit and thesecond fluid conduit are simultaneously kept open. The cam may beconstructed to provide more than merely a fully opened state and a fullyclosed state for each of the first and second fluid conduits. Morespecifically, the cam may be constructed to additionally include afinite number or an infinite number (i.e. continuously adjustable) ofintermediate positions having flow rates varying by equal or unequalincrements between the fully opened state and the fully closed state.

According to another aspect, there can be provided a delivery device foruse in delivering a therapeutic and/or diagnostic object, such as aninflatable pressure-attenuating device, to an anatomical structurewithin a patient. The delivery device can include a delivery tube, aninflation tube, and a release mechanism, among other features. In someembodiments, the delivery device can comprise (a) a housing; (b) a tubeextending from a distal end of the housing, the tube having a proximalend, a distal end, and at least one longitudinal channel; (c) a firstfluid supply, the first fluid supply comprising a volume of a firstfluid; (d) a second fluid supply, the second fluid supply comprising avolume of a second fluid; and (e) a connection system, the connectionsystem connecting each of the first fluid supply and the second fluidsupply to the at least one longitudinal channel of the tube.

According to another aspect, there can be provided a delivery device foruse in delivering an inflatable medical device, such as an inflatablepressure-attenuating device, to an anatomical structure within apatient. The delivery device can comprise (a) a housing; (b) aninflation tube extending from a distal end of the housing, the inflationtube having a proximal end, a distal end, and a longitudinal channel,the distal end of the inflation tube being insertable into an inflatablemedical device for use in delivering at least one inflation medium tothe inflatable medical device; and (c) a push-off member slidablymounted relative to the inflation tube, the push-off member comprising adistal end slidable distally past the distal end of the inflation tubeto decouple the inflation tube from the inflatable medical device.

According to another aspect, there can be provided a delivery device foruse in delivering an inflatable medical device, such as an inflatablepressure-attenuating device, to an anatomical structure within apatient. The delivery device can comprise (a) a housing, (b) aninflation tube extending from the housing, the inflation tube comprisinga distal end adapted for coupling to an inflatable medical device, and(c) a decoupling member for decoupling the distal end of the inflationtube from the inflatable medical device, (d) wherein the housing ismarked with markings communicating a sequence of steps for operation ofthe delivery device.

According to another aspect, there can be provided a delivery device foruse in delivering an inflatable medical device, such as apressure-attenuating device, to an anatomical structure within apatient. The delivery device can comprise (a) a housing, the housingcomprising a first opening, a second opening and a third opening; (b) atrigger, the trigger being pivotally mounted on the housing; (c) aninflation tube extending through the second opening of the housing, theinflation tube having a proximal end, a distal end, and at least onelongitudinal channel, the distal end of the inflation tube extendingdistally from the second opening of the housing and being insertableinto a medical device for use in delivering at least one inflationmedium to the medical device; (d) a push-off member coupled to thetrigger and slidably mounted relative to the inflation tube, thepush-off member comprising a distal end slidable distally past thedistal end of the inflation tube to decouple the inflation tube from themedical device; (e) a first syringe, the first syringe being mountedwithin the first opening of the housing and comprising a volume of afirst inflation medium, the first inflation medium being, for example,air, the first syringe being adapted for connection to the at least onelongitudinal channel of the inflation tube; and (f) a second syringe,the second syringe being mounted within the third opening of the housingand comprising a volume of a second inflation medium, the secondinflation medium being, for example, at least one high vapor pressuremedium, such as at least one liquid perfluorocarbon, the second syringebeing adapted for connection to the at least one longitudinal channel ofthe inflation tube. The housing may also be marked with markingscommunicating a sequence of steps for operation of the delivery device.

According to another aspect, there can be provided a delivery device foruse in delivering a medical device to an anatomical structure within apatient. The delivery device can comprise (a) a catheter, the catheterhaving a channel and a window, the channel being dimensioned to receivethe medical device, the window communicating with the channel and beingdimensioned for passage of the medical device therethrough; and (b) acover slidably mounted over the catheter for selectively covering anduncovering the window.

According to another aspect, a kit can be provided. The kit can comprise(a) a sealed compartment; (b) a support disposed within the sealedcompartment; (c) a delivery device disposed within the sealedcompartment and mounted on the support, the delivery device comprising(i) a housing, (ii) an inflation tube extending from a distal end of thehousing, the inflation tube comprising a distal end, (iii) a push-offmember slidably mounted relative to the inflation tube, the push-offmember comprising a distal end slidable distally past the distal end ofthe inflation tube, and (iv) a catheter extending from the distal end ofthe housing, the catheter mounted around the push-off member andextending distally beyond the distal end of the inflation tube, thecatheter comprising a window in the proximity of the distal end of theinflation tube; (d) an inflatable medical device, the inflatable medicaldevice being disposed within the catheter in a deflated and folded stateand being mounted on the distal end of the inflation tube to receivefluid therefrom; and (e) a syringe disposed within the sealedcompartment and mounted on the support separate from the deliverydevice, the syringe containing a volume of an inflation medium, such asair, to be injected into the inflatable medical device; (f) wherein allof the sealed compartment, the support, the delivery device, theinflatable medical device, and the syringe are sterilizable by the samesterilization technique, which may be, for example, gamma radiationsterilization, ethylene oxide sterilization, or electron beamsterilization.

According to another aspect, there can be provided the combination of adelivery device and an inflatable medical device. The delivery devicecan comprise a housing, an inflation tube, a push-off member, and acatheter. The inflation tube can extend from a distal end of thehousing. The inflation tube can comprise a distal end. The push-offmember can be slidably mounted relative to the inflation tube, and thepush-off member can comprise a distal end slidable distally past thedistal end of the inflation tube. The catheter can extend from thedistal end of the housing, and the catheter can be positioned around thepush-off member and can extend distally beyond the distal end of theinflation tube. The catheter can comprise a window aligned with thedistal end of the inflation tube. The inflatable medical device can bedisposed within the catheter in a deflated and folded state and can bemounted on the distal end of the inflation tube to receive fluidtherefrom.

According to another aspect, there can be provided an inflatable medicaldevice. The inflatable medical device can comprise (a) an inflatablecell, the inflatable cell comprising an opening, wherein the inflatablecell is seamless; and (b) a fluid valve mounted in the opening of theinflatable cell.

According to another aspect, there can be provided an inflatable medicaldevice. The inflatable medical device can comprise (a) an inflatablecell, the inflatable cell comprising an opening; and (b) a fluid valvemounted in the opening of the inflatable cell, wherein the fluid valvecomprises a proximal portion, an intermediate portion, and a distalportion, the intermediate portion being generally cylindrical in shape,and the distal portion being generally flat.

According to another aspect, there can be provided a medical device. Themedical device can comprise an inflatable cell, wherein over 95% of theexternal surface of the inflatable cell is continuously arcuate and lessthan 5% of the surface area of the inflatable cell is not continuouslyarcuate.

According to another aspect, there can be provided a medical device. Themedical device can comprise an inflatable cell, wherein the ratio ofcontinuously arcuate surface area to non-arcuate surface area for theinflatable cell is between about 100:1 to 1500:1.

According to another aspect, there can be provided a medical device. Themedical device can comprise an inflatable cell, the inflatable cellcomprising a bulb portion and a tail portion, wherein the ratio of thediameter of the bulb portion to the tail portion is between about 6:1and 20:1.

According to another aspect, there can be provided a removal device. Theremoval device can include at least one manually-actuatable member; andat least one movable arm or jaw, the at least one movable jaw beingoperable by actuation of the at least one manually-actuatable member.

According to another aspect, there can be provided a removal device. Theremoval device can comprise (a) at least one manually-actuatable member;(b) at least two jaws, at least one of the at least two jaws beingmoveable by actuation of the at least one manually-actuatable member;(c) a cystoscope, the cystoscope being positioned to enable observationof the at least two jaws, wherein the cystoscope is a wide anglecystoscope.

According to another aspect, there can be provided a removal device. Theremoval device can comprise (a) at least one manually-actuatable member;(b) at least two jaws, at least one of the at least two jaws beingmovable by actuating the at least one manually-actuatable member,wherein at least one of the at least two jaws comprises a grippingmember, such as teeth, to securely hold an object to be removed andwherein at least one of the at least two jaws comprises a puncturingmember, such as a blade, scissor, pin, hook, or the like, to puncturethe object to be removed.

According to another aspect, there can be provided a system for use intreating a patient. The system can comprise (a) an access device for usein providing access to an anatomical structure within the patient, theaccess device comprising an elongated sheath and an obturator removablymounted within the elongated sheath; (b) a pressure-attenuating device;and (c) a delivery device, the delivery device comprising a catheterremovably insertable through the elongated sheath of the access deviceand into the anatomical structure, the pressure-attenuating device beingdisposed within the catheter of the delivery device.

According to another aspect, there can be provided a method of treatinga patient. The method can comprise the steps of (a) providing an accessdevice, the access device comprising an elongated sheath and anobturator removably mounted within the elongated sheath; (b) inserting adistal end of the access device into an anatomical structure within apatient, a proximal end of the access device remaining external to thepatient; (c) withdrawing the obturator from the patient, therebycreating a passageway to the anatomical structure; and (d) delivering apressure-attenuating device to the anatomical structure through thepassageway.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other features, aspects and advantages are described belowwith reference to the drawings, which are intended to illustrate but notto limit the invention. In the drawings, like reference charactersdenote corresponding features consistently throughout similarembodiments.

FIG. 1 is a side view of a first embodiment of some of the components ofa system for treating a patient;

FIGS. 2(a) through 2(c) are side, partially exploded side, andside-partly in section, views, respectively, of the access device shownin FIG. 1;

FIGS. 3(a) and 3(b) are side and section views, respectively, of the hubshown in FIG. 2(b);

FIGS. 4(a) and 4(b) are side and section views, respectively, of thesheath shown in FIG. 2(b);

FIGS. 5(a) through 5(c) are side, proximal, and distal views,respectively, of the handle shown in FIG. 2(b);

FIG. 6 is a bottom view of one half of the handle shown in FIGS. 5(a)through 5(c);

FIGS. 7(a) and 7(b) are side and section views, respectively, of thevalve assembly shown in FIG. 2(b);

FIG. 8(a) is a side view, partly in section, of the combination of thehandle shown in FIGS. 5(a) through 5(c) and the valve assembly shown inFIGS. 7(a) and 7(b);

FIG. 8(b) shows the combination of the handle and valve assembly of FIG.8(a), together with an O-ring;

FIGS. 9(a) and 9(b) are section and distal views, respectively, of theseal shown in FIG. 2(b);

FIGS. 10(a) and 10(b) are side and section views, respectively, of theobturator shown in FIG. 2(b);

FIGS. 11(a) and 11(b) are side and section views, respectively, of theobturator handle shown in FIG. 2(b);

FIGS. 12(a) and 12(b) are side and section views, respectively, of thehandle plug shown in FIG. 2(b);

FIGS. 13(a) and 13(b) are side and section views, respectively, of thesleeve shown in FIG. 2(b);

FIGS. 14(a) and 14(b) are side and section views, respectively, of theslide ring assembly inner member shown in FIG. 2(b);

FIGS. 15(a) and 15(b) are side and section views, respectively, of theslide ring assembly outer member shown in FIG. 2(b);

FIG. 16 is a distal view of the slide ring assembly O-ring shown in FIG.2(b);

FIGS. 17(a) and 17(b) are fragmentary section views of the access deviceof FIG. 1, with the slide ring assembly being shown in a distal positionand in a proximal position, respectively;

FIG. 18 is a side view of the tether shown in FIG. 2(b);

FIGS. 19(a) through 19(c) are top, bottom, and left side views,respectively, of the retaining card shown in FIG. 2(b);

FIGS. 20A-B are flowcharts, schematically illustrating methods ofimplanting the access device of FIGS. 2(a) through 2(c) in a patient;

FIGS. 21(a) through 21(d) are side views, some partly in section and/orbroken away in part, illustrating certain steps of the method shown inFIG. 20;

FIGS. 22(a) through 22(c) are fragmentary perspective, partly insection, fragmentary distal, and fragmentary section views,respectively, of a first alternate embodiment to the access device ofFIG. 1;

FIG. 23 is a fragmentary section view of a second alternate embodimentto the access device of FIG. 1;

FIG. 24 is a fragmentary section view of a third alternate embodiment tothe access device of FIG. 1;

FIG. 25 is a fragmentary section view of a fourth alternate embodimentto the access device shown in FIG. 1;

FIG. 26 is a top view of a fifth alternate embodiment to the accessdevice shown in FIG. 1, the access device being shown with its slidering assembly in a proximal position and with its protective sleeveeverted over its sheath;

FIG. 27 is an enlarged fragmentary perspective view of the access deviceof FIG. 26, with one of the two housing portions, the two stopcocks, andcertain of the internal components not being shown;

FIG. 28 is top view of a sixth alternate embodiment to the access deviceshown in FIG. 1, the access device being shown with its slide ringassembly in a proximal position and with its protective sleeve evertedover its sheath;

FIGS. 29(a) through 29(c) are top, side, and perspective views,respectively, of a seventh alternate embodiment to the access deviceshown in FIG. 1, the access device being shown with its slide ringassembly in a proximal position and with its protective sleeve evertedover its sheath;

FIG. 30 is a simplified schematic representation of the cam-actuatedvalve mechanism of the access device shown in FIGS. 29(a) through 29(c);

FIG. 31 is a simplified schematic representation of a first alternateembodiment to the cam-actuated valve mechanism shown in FIG. 30;

FIGS. 32(a) through 32(d) are simplified schematic representations of asecond alternate embodiment to the cam-actuated valve mechanism shown inFIG. 30, the cam-actuated valve mechanism being shown in closed, fill,drain, and flush positions, respectively;

FIGS. 33(a) through 33(c) are simplified schematic representations of athird alternate embodiment to the cam-actuated valve mechanism shown inFIG. 30, the cam-actuated valve mechanism being shown in closed, fill,and drain positions, respectively;

FIG. 34 is a simplified schematic representation of a fourth alternateembodiment to the cam-actuated valve mechanism shown in FIG. 30, thecam-actuated valve mechanism being constructed to be radiallyinwardly-compressing;

FIG. 35 is a simplified schematic representation of a fifth alternateembodiment to the cam-actuated valve mechanism shown in FIG. 30, thecam-actuated valve mechanism being constructed to be radiallyoutwardly-compressing;

FIGS. 36(a) through 36(c) are partly in section top, partly in sectionenlarged fragmentary top, and partly in section perspective views,respectively, of an eighth alternate embodiment to the access deviceshown in FIG. 1, the access device being shown without one of its twohousing portions and without its protective sleeve;

FIGS. 37(a) and 37(b) are top views, partly in section, of a ninthalternate embodiment to the access device shown in FIG. 1, the accessdevice being shown with its slide in its distal and proximal positions,respectively, the access device also being shown without one of its twohousing portions and without its protective sleeve;

FIG. 38 is a top view of the slide shown in FIGS. 37(a) and 37(b);

FIGS. 39(a) and 39(b) are top views, partly in section, of a tenthalternate embodiment to the access device shown in FIG. 1, the accessdevice being shown with its slide in its distal and proximal positions,respectively, the access device also being shown without one of its twohousing portions and without its protective sleeve;

FIG. 40 is a perspective view of the slide shown in FIGS. 39(a) and39(b);

FIGS. 41(a) through 41(d) are perspective, side, side partly in section,and partially exploded perspective views, respectively, of an eleventhalternate embodiment to the access device shown in FIG. 1, the accessdevice being shown in FIGS. 41(a) through 41(c) with the cam-actuatedswitch in the closed position and with the slide ring assembly in itsdistal position;

FIGS. 42(a) and 42(b) are perspective views of the housing shown inFIGS. 41(a) through 41(d);

FIGS. 43(a) and 43(b) are side and perspective views, respectively, ofthe left housing half shown in FIGS. 42(a) and 42(b);

FIGS. 44(a) and 44(b) are side and perspective views, respectively, ofthe right housing half shown in FIGS. 42(a) and 42(b);

FIGS. 45(a) through 45(d) are perspective, side, front and rear views,respectively, of the hub shown in FIG. 41(d);

FIGS. 46(a) through 46(e) are side, front, rear, perspective and bottomviews, respectively, of the cam shown in FIG. 41(d);

FIG. 47 is a perspective view of the access device shown in FIGS. 41(a)through 41(d), with the cam being positioned in one of its two openpositions;

FIG. 48 is a perspective view of the access device shown in FIGS. 41(a)through 41(d), with the cam being positioned in the other of its twoopen positions;

FIGS. 49(a) through 49(c) are fragmentary rear views of the accessdevice shown in FIGS. 41(a) through 41(d), certain components of theaccess device not being shown for clarity, with the cam being shown inits closed position, in one of its two open positions, and in the otherof its two open positions, respectively;

FIGS. 50(a) through 50(c) are enlarged perspective, front, and sideviews, respectively, of the sheath shown in FIG. 41(d);

FIG. 51 is an enlarged side view, partly in section, of the combinationof the hub, the valve assembly, the seal, and the cap shown in FIGS.41(c) and 41(d);

FIGS. 52(a) through 52(d) are side, front, rear, and perspective views,respectively, of the cap shown in FIGS. 41(a) through 41(d);

FIG. 53 is an exploded perspective view of the combination of theobturator and the obturator handle shown in FIGS. 41(a) through 41(d);

FIG. 54 is an enlarged fragmentary side view of the obturator shown inFIG. 53;

FIGS. 55(a) and 55(b) are enlarged perspective views of the obturatorhandle shown in FIG. 53;

FIGS. 56(a) and 56(b) are exploded perspective and exploded side views,respectively, of the combination of the sheath, the protective sleeveand the slide ring assembly shown in FIG. 41(d);

FIG. 57 is an enlarged section view of the combination of the housing,the sheath and the slide ring assembly shown in FIG. 41(d), the slidering assembly being shown locked in its proximal position;

FIGS. 58(a) through 58(d) are perspective, side, section, and partiallyexploded perspective views, respectively, of a twelfth alternateembodiment to the access device shown in FIG. 1, the access device beingshown in FIGS. 58(a) through 58(c) with the cam-actuated switch in theclosed position and with the slide ring assembly in its proximalposition;

FIG. 59 is a perspective view of the housing shown in FIGS. 58(a)through 58(c);

FIGS. 60(a) and 60(b) are side and perspective views, respectively, ofthe left housing half shown in FIG. 59;

FIGS. 61(a) and 61(b) are side and perspective views, respectively, ofthe right housing half shown in FIG. 59;

FIGS. 62(a) and 62(b) are side and section views, respectively, of thehub shown in FIG. 58(d);

FIGS. 63(a) through 63(c) are perspective, bottom, and enlargedfragmentary perspective views, respectively, of the cam shown in FIG.58(d);

FIG. 64 is a perspective view of the access device shown in FIGS. 58(a)through 58(d), with the cam being positioned in one of its two openpositions (the obturator and the protective sleeve not being shown);

FIG. 65 is a perspective view of the access device shown in FIGS. 58(a)through 58(d), with the cam being positioned in the other of its twoopen positions (the obturator and the protective sleeve not beingshown);

FIGS. 66(a) and 66(b) are bottom and perspective views, respectively, ofthe combination of the cam, the hub, and the compliant tubes of theaccess device shown in FIGS. 58(a) through 58(d), with the cam shown inits closed position;

FIGS. 67(a) through 67(c) are bottom views of the combination of thecam, the hub, the compliant tubes, the sheath, and the slide ringassembly of the access device shown in FIGS. 58(a) through 58(d), withthe cam shown in its closed position, with the cam shown in one of itstwo open positions, and with the cam shown in the other of its two openpositions, respectively;

FIGS. 68(a) through 68(c) are front, side, and rear views, respectively,of the cap shown in FIGS. 58(a) through 58(d);

FIG. 69 is an exploded perspective view of the combination of theobturator and obturator handle shown in FIG. 58(b);

FIGS. 70(a) and 70(b) are enlarged front perspective and enlarged rearperspective views, respectively, of the obturator handle shown in FIG.69;

FIGS. 71(a) and 71(b) are perspective and side views, respectively, of afirst alternate obturator handle to the obturator handle shown in FIGS.58(a) and 58(b);

FIG. 72 is a perspective view of a first alternate left housing half tothe left housing half shown in FIGS. 60(a) and 60(b);

FIG. 73 is an exploded perspective view of the combination of thesheath, the protective sleeve and the slide ring assembly shown in FIG.58(d);

FIG. 74 is an enlarged side view of the access device shown in FIGS.58(a) through 58(d), with the right housing half not being shown andwith the slide ring assembly being shown in an intermediate positionbetween in proximal and distal positions;

FIG. 75 is an enlarged fragmentary perspective view of the inner memberof the slide ring assembly and the sheath shown in FIG. 73;

FIG. 76 is a perspective view of a first alternate cam to the cam shownin FIGS. 63(a) through 63(c);

FIGS. 77(a) and 77(b) are perspective and partly exploded perspectiveviews, respectively, of a second alternate cam to the cam shown in FIGS.63(a) through 63(c);

FIGS. 78(a) and 78(b) are proximal perspective and distal perspectiveviews, respectively, of the delivery device shown in FIG. 1, with thetwo syringes not being shown;

FIG. 79 is a side view, partly in section, of the delivery device shownin FIG. 1, with one of the housing halves removed to reveal certaincomponents located within the housing, the delivery device being shownwith the pressure-attenuating device of FIG. 1 in a deflated stateloaded thereinto;

FIG. 80 is a partially exploded perspective view of the delivery deviceshown in FIGS. 78(a) and 78(b);

FIGS. 81(a) and 81(b) are left and right side views, respectively, ofthe left housing half of the delivery device shown in FIGS. 78(a) and78(b);

FIGS. 82(a) and 82(b) are left and right side views, respectively, ofthe right housing half of the delivery device shown in FIGS. 78(a) and78(b);

FIG. 83 is a section view of the fluid connector shown in FIG. 79;

FIG. 84 is a section view of one of the check valve shown in FIG. 79;

FIG. 85 is a section view of the inflation tube shown in FIG. 79;

FIGS. 86(a) through 86(e) are left side, right side, proximal, distal,and section views, respectively, of the carriage shown in FIG. 79;

FIG. 87 is a section view of the push-off tube shown in FIG. 79;

FIGS. 88(a) and 88(b) are side and proximal views, respectively, of thetrigger shown in FIG. 79;

FIGS. 89(a) and 89(b) are side and section views, respectively, of thelinkage shown in FIG. 79;

FIG. 90 is a side view of the safety shown in FIG. 79;

FIGS. 91(a) and 91(b) are fragmentary side views, partly in section, ofthe delivery device shown in FIG. 79 with one of the housing halves andthe syringes removed and with the safety being shown in a locked stateand in an unlocked state, respectively;

FIGS. 92(a) through 92(c) are fragmentary side, fragmentary section, andfragmentary top views, respectively, of the window catheter shown inFIG. 79;

FIGS. 92(d) through 92(l) show embodiments of window catheter distalportion;

FIG. 93 is a distal view of the sealing ring shown in FIG. 79;

FIGS. 94 and 95 are side views, broken away in part, of the syringesshown in FIG. 79;

FIGS. 96(a) and 96(b) are side views of an alternate embodiment to thedelivery device shown in FIG. 1, the alternate embodiment including aretractable cover shown in distal and proximal positions, respectively;

FIG. 97 is a side view of the retractable cover shown in FIGS. 96(a) and96(b);

FIGS. 98(a) through 98(d) show additional embodiments of the retractablecover shown in FIGS. 96(a) and 96(b);

FIGS. 99(a) through 99(c) are perspective views of thepressure-attenuating device shown in FIG. 1 in an inflated state, thefluids within the inflated device not being shown;

FIG. 100 is a fragmentary section view of the pressure-attenuatingdevice of FIGS. 99(a) through 99(c);

FIG. 101 is a top view of the valve shown in FIGS. 99(a) through 99(c);

FIG. 102 is a flowchart, schematically illustrating one method ofmanufacturing the pressure-attenuating device of FIGS. 99(a) through99(c);

FIGS. 103(a) through 103(e) are section views, illustrating parts ofcertain steps of the method shown in FIG. 102;

FIG. 104 is a fragmentary side view, partly in section, showing thepressure-attenuating device of FIGS. 99(a) through 99(c) stored in adeflated, folded state within the window catheter of the delivery deviceof FIGS. 78(a) and 78(b);

FIG. 105 is a top view of the pressure-attenuating device of FIGS. 99(a)through 99(c), the pressure-attenuating device being shown in adeflated, flattened state prior to being folded;

FIG. 106 is a top view of one embodiment of a sterilizable kitcontaining certain components of the system of FIG. 1;

FIG. 107 is a flowchart, schematically illustrating one method ofimplanting the pressure-attenuating device of FIGS. 99(a) through 99(c)in a patient;

FIGS. 108(a) through 108(d) are fragmentary side views, partly insection, illustrating parts of certain steps of the method shown in FIG.107;

FIGS. 109(a) through 109(d) are side, partially exploded fragmentaryperspective, fragmentary top, and fragmentary top, broken away in part,views, respectively, of the removal device shown in FIG. 1;

FIGS. 110 and 111 are respective section views of the scope connectorand ring shown in FIG. 109(a);

FIGS. 112, 113 and 114 are respective fragmentary section views of thescope guide, cystoscope, and support shown in FIG. 109(a);

FIG. 115 is a section view of the bracket shown in FIG. 109(a);

FIG. 116 is a fragmentary section view of the rod shown in FIG. 109(a);

FIG. 117 is a section view of the connector shown in FIG. 109(b);

FIG. 118 is a section view of the linking arm shown in FIG. 109(b);

FIG. 119 is a section view of the linking arm shown in FIG. 109(b);

FIGS. 120(a) through 120(d) are left side, right side, top, and sectionviews, respectively, of one of the jaws shown in FIG. 109(b); FIGS. 120(e) and 120(f) are right and top section views of an alternative designof the jaws shown in FIG. 109(b);

FIGS. 121(a) through 121(d) are left side, right side, top, and sectionviews, respectively, of the other jaw shown in FIG. 109(b);

FIG. 122 is a flowchart, schematically illustrating one method of usingthe removal device of FIG. 109(a) to remove the pressure-attenuatingdevice of FIG. 99(a) from a patient;

FIGS. 123(a) through 123(d) are fragmentary side views, partly insection, illustrating certain parts of steps of the method shown in FIG.122;

FIGS. 124 and 125 are side views of first and second alternateembodiments to the sheath shown in FIGS. 4(a) and 4(b);

FIGS. 126(a) and 126(b) are fragmentary top views of a first alternateembodiment to the removal device shown in FIG. 1, the jaws of theremoval device being shown in a closed state and in an open state,respectively;

FIG. 127 is a fragmentary section view of the removal device of FIGS.126(a) and 126(b);

FIGS. 128(a) and 128(b) are fragmentary top views of a second alternateembodiment to the removal device shown in FIG. 1, the jaws of theremoval device being shown in a closed state and in an open state,respectively;

FIG. 129 is a fragmentary section view of the removal device of FIGS.128(a) and 128(b);

FIG. 130 is a side view of a third alternate embodiment to the removaldevice shown in FIG. 1, the removal device being shown in an open state;

FIG. 131 is an enlarged fragmentary side view of a proximal portion ofthe removal device shown in FIG. 130;

FIGS. 132(a) through 132(c) are enlarged fragmentary side, top, andperspective views, respectively, of a distal portion of the removaldevice shown in FIG. 130;

FIGS. 133(a) through 133(c) are side, perspective, and exploded views,respectively, of a fourth alternate embodiment to the removal deviceshown in FIG. 1, the removal device being shown with the two jaws in aclosed state;

FIG. 134 is a side view of the removal device shown in FIGS. 133(a)through 133(c), the removal device being shown with the two jaws in anopen state;

FIG. 135 is an enlarged fragmentary exploded view of a distal portion ofthe removal device shown in FIGS. 133(a) through 133(c), the two jawsbeing shown in a closed state, the cystoscope and the wires not beingshown;

FIGS. 136(a) and 136(b) are enlarged fragmentary bottom and top views,respectively, of a distal portion of the removal device shown in FIGS.133(a) through 133(c), the two jaws of the removal device being shown ina closed state, the cystoscope not being shown;

FIGS. 137(a) and 137(b) are enlarged fragmentary top and perspectiveviews, respectively, of the distal portion of the removal device shownin FIGS. 133(a) through 133(c), the two jaws of the removal device beingshown in an open state, the cystoscope not being shown;

FIG. 138 is an enlarged side view of the handle assembly shown in FIGS.133(a) through 133(c);

FIGS. 139(a) through 139(c) are enlarged side, top, and perspectiveviews, respectively, of the jaw assembly shown in FIGS. 133(a) through133(c), the two jaws of the jaw assembly shown in a closed state;

FIGS. 140(a) and 140(b) are enlarged top and perspective views,respectively, of the jaw assembly shown in FIG. 134, the two jaws shownin an open state;

FIGS. 141(a) and 141(b) are enlarged end and side views, respectively,of the tube body shown in FIGS. 133(a) through 133(c);

FIGS. 142(a) and 142(b) are side and top views, respectively, of thewire shown in FIGS. 133(a) through 133(c);

FIG. 143 is an enlarged fragmentary perspective view of the distal endof the wire shown in FIGS. 141(a) and 141(b);

FIG. 144 is an enlarged fragmentary side view of the proximal end of thewire shown in FIGS. 141(a) and 141(b); and

FIGS. 145(a) and 145(b) are enlarged side and perspective views,respectively, of one of the needles shown in FIG. 133(c).

FIG. 146 illustrates an embodiment of an inflatable cell compressiontest fixture.

FIGS. 147(a) through (d) illustrate various views of an embodiment of atest vessel for the inflatable cell compression test fixture of FIG.146.

FIGS. 148(a) through (d) illustrate various views of an embodiment of apiston for the inflatable cell compression test fixture of FIG. 146.

FIGS. 149(a) through (e) illustrate various views of an embodiment of acentering disk for the inflatable cell compression test fixture of FIG.146.

FIGS. 150(a) through (e) illustrate various views of an embodiment of abase for the inflatable cell compression test fixture of FIG. 146.

FIGS. 151(a) through (d) illustrate various views of an embodiment of abracket post for the inflatable cell compression test fixture of FIG.146.

FIGS. 152(a) through (d) illustrate various views of an embodiment of aheater bracket for the inflatable cell compression test fixture of FIG.146.

FIG. 153 illustrates a fragmentary section view of the inflatable cellcompression test fixture of FIG. 146.

FIG. 154 illustrates an exemplary test data table.

FIGS. 155-158 illustrate an exemplary pressure volume charts.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Medical devices, methods, and systems related thereto for use within thebody are disclosed. The medical devices and medical systems can includepressurized therapeutic devices, implants, implant delivery devices,implant retrieval devices, expandable or compressible membraneenclosures or balloons, sponges, foams, attenuators, space occupyingmembers, and space creating devices, and therapeutic devices. Thoughurology and use in the bladder will be primarily discussed, it will beunderstood that the systems and methods can be used elsewhere. Themedical devices and medical systems can be used for many purposes and inmany places within the body including, but not limited to, the followingsystems of the human body: cardiovascular, pulmonary, renal/urological,gastrointestinal, hepatic/biliary, gynecological, neurological,musculoskeletal, otorhinolaryngological and ophthalmic, as well as inand around organs of the body, and in intra- and inter-organ spaces.

In one particular aspect, the disclosure relates generally to the fieldof urology, and in particular to the treatment of disorders of theurinary tract caused by sudden fluctuations of intravesical pressure.More specifically, in this aspect, methods, systems, and devices areprovided for the treatment of urinary disorders, such as incontinence,urgency, frequency, interstitial cystitis, irritable bladder syndrome,and neurogenic bladders.

Some embodiments provide methods, systems, and devices for treatingand/or compensating for reduced dynamic compliance of the bladder. Inone embodiment, a device having a compressible element is placed withinthe human urinary bladder in a manner that allows the compressibleelement to act as a pressure attenuator to attenuate transient pressureevents. The term “attenuator” refers generally to devices that attenuatepressure, force, or energy by dissipating or dampening the pressure,force, or energy. Gases, such as atmospheric air, carbon dioxide,nitrogen, and certain perfluorocarbons (PFC), are very compressible inthe pressure ranges typically encountered in the human bladder and maybe used in attenuation devices inserted in the bladder. Furthermore,when compared to the tissues encompassing liquid, gases aresignificantly more compliant than the immediate environment. Theaddition of a volume of gas can act as a low or variable rate spring inseries with the native fluidic circuit of the urinary tract.

In accordance with one embodiment, an attenuation device is placedwithin the human urinary bladder. The attenuation device can be apressurized container with a positive or negative pressure. Thecontainer can take many forms including a sphere. The attenuation devicemay be untethered in the bladder and may remain in the bladder forbetween several hours and one year. The attenuation device can be asmall elastomeric gas cell with a relaxed (unstretched) volume ofbetween about 0.1 and 500 cc, more preferably between about 1 and 180cc, and more preferably still, between about 10 and 60 cc. Theattenuation device can be a unitary component or can comprise two ormore subcomponents. The attenuation device can be made with a seam orwithout a seam but preferably is made without a seam. The attenuationdevice can have a substantially uniform wall thickness of between about0.25 inch to 0.0001 inch, more preferably between 0.0001 inch and 0.005inch, but could vary greatly in wall thickness and still perform theintended function.

In the embodiment described above, attenuation devices having gas cellsthat are free-floating in the bladder have been described. In otherembodiments, gas cells or similar attenuation devices could besurgically affixed to the bladder wall through the use of suture,staples or other accepted methods or could be placed submucosally orintramuscularly within the bladder wall. Some embodiments could induceendothelial encapsulation. Other embodiments could also includeattenuation devices with programmable, variable and adjustable buoyancyby using ballasting, specific inflation/deflation solutions, alternativematerials of construction or by other means.

Referring now to FIG. 1, there is shown a side view of components of afirst embodiment of a system for treating a patient, the treatmentsystem being represented generally by reference numeral 11. (For ease ofillustration and understanding, certain aspects of system 11 may not beshown in FIG. 1.)

System 11 may comprise an access device 13, a delivery device 15, apressure-attenuating device 17, and a removal device 19. The accessdevice may be used to create a trans-urethral passageway to a patient'sbladder. The delivery device may be inserted through the passagewaycreated by the access device and may be used to deliver thepressure-attenuating device to the bladder in a compacted state, thenmay be used to inflate the pressure-attenuating device, and then may beused to release the inflated, pressure-attenuating device. The removaldevice may be inserted through the passageway created by the accessdevice and may be used to view the bladder and/or to capture, to deflateand to remove the pressure-attenuating device.

Each of access device 13, delivery device 15, and pressure-attenuatingdevice 17 may be a single-use (i.e., disposable) device or amultiple-use (i.e., reusable) device, but each is preferably asingle-use device. Removal device 19 may be a single-use device or amultiple-use device, but preferably is a multiple-use device.

Access Device

As has been mentioned, an access device may be used to create apassageway into the body. For example, the passageway can be atrans-urethral passageway to a patient's bladder. The access device maybe used to drain fluid from the body, such as from the bladder. Theaccess device can be used to protect tissue between the access entrylocation and the exit location within the body. The access device mayfurther be used as a positioning device to properly position othertools, such as the delivery device within the body. For example, theaccess device can include a meatal stop, to properly position portionsof the delivery device within the bladder.

An access device may include one or more of a housing assembly, a sheathassembly, and a fluid control system. A housing assembly can compriseone or more housing structures that define a body of the access device.

A sheath assembly can comprise an elongated sheath or cannula, and alongitudinal channel extending therethrough. In some embodiments, aswill be discussed more fully below, the sheath assembly may include aslide ring assembly that is slidably mounted around the sheath, and itmay include a protective sleeve. The slide ring assembly can be movedbetween a distal position and a proximal position. In some embodimentsthe slide ring assembly can have one or more mechanisms to secure theslide ring assembly in the distal position and/or the proximal position,and positions therebetween. The protective sleeve can be coupled to theslide ring assembly. In some embodiments the access device can includean obturator that can be removably mounted within the longitudinalchannel of the sheath.

A fluid control system can control fluid communication between theanatomical structure within the patient and the access device. Forexample, the fluid control system can be used to drain the bladder of apatient. The fluid control system can have one or more fluid conduits influid communication with the sheath. The fluid conduits can be used toremove and/or deliver fluid to/from the patient. The fluid controlsystem can have one or more mechanisms to control the rate of fluidtransfer through the access device. In some embodiments the fluidcontrol system can provide a fully open fluid conduit or a fully closedfluid conduit. In some embodiments, the fluid control system can have amechanism to provide a variable flow rate for each fluid conduit. Insome embodiments the flow rate of each fluid conduit can be controlledindividually.

Additional embodiments of access devices are described in U.S. PatentApplication Publication No. 2010/0222802, incorporated herein byreference, and referring to cannulas, sheaths, tubular bodies, and/ortubular hubs, metal stop surface, etc., often as part of a deliverysystem. See for example, paragraphs [0153]-[0206] and FIGS. 6-7B and9-18H. Embodiments of an access device, often as part of a deliverysystem, are also provided in U.S. Pat. No. 6,976,950, incorporated byreference herein. See for example: FIGS. 6-11A, 34A-35B and 48A-48D, andthe accompanying discussion, including at columns 13-16, and 35.

As shown in FIGS. 2(a) through 2(c), access device 13 may include ahousing assembly, a sheath assembly, and a fluid control system. Thehousing assembly may comprise a handle 71. The sheath assembly maycomprise a cannula or sheath 61, a dilator or obturator 131, anobturator handle 151, a handle plug 171, a protective sleeve 181, aslide ring assembly 191, and one or more restraining mechanisms 241 and261. The fluid control system may comprise one or more of a hub 21, avalve assembly 91, a seal 125, and a fluid extension line 281. In someembodiments, the access device 13 may simply comprise a cannula, but mayalso include a valve assembly and an obturator. It will be understoodthat other combinations of components could also be used. Each of thecomponents will now be discussed in detail.

Referring now to FIGS. 3(a) and 3(b), the hub 21 may comprise a unitarystructure, preferably made of a hard, medical-grade polymer or asimilarly suitable material. Hub 21 may be shaped to include a firsttubular member 23 and a second tubular member 25.

First tubular member 23 may comprise an open proximal end 27, an opendistal end 29, and a longitudinal channel 31 extending from proximal end27 to distal end 29. Member 23 may include a generally frusto-conicalproximal portion 32-1 of comparatively greater inside diameter, agenerally cylindrical distal portion 32-2 of comparatively lesser insidediameter, and a generally cylindrical intermediate portion 32-3 ofintermediate inside diameter. Proximal portion 32-1 may be shaped toinclude an internal helical thread 33 extending distally a shortdistance from proximal end 27. Distal portion 32-2 and intermediateportion 32-3 may be interconnected by a frusto-conical wall 35. Theexterior of distal portion 32-2 may be shaped to include first andsecond circumferential ribs 37 and 39, respectively, and first andsecond axial ribs 41 and 43, respectively.

Second tubular member 25, which may be oriented generallyperpendicularly to first tubular member 23, may comprise an openproximal end 45, an open distal end 47, and a longitudinal channel 49that extends from proximal end 45 to distal end 47 and that tapersgradually in diameter from proximal end 45 to distal end 47. Proximalend 45 may be in the shape of a female luer lock connector. Distal end47 may be positioned relative to first tubular member 23 so that thedistal end of channel 49 opens into channel 31 at a location withinintermediate portion 32-3. A barb 51 may be formed on the exterior ofmember 25 proximate to distal end 47 in such a way that barb 51 anddistal end 47 jointly define a waist 53 therebetween.

Hub 21 may further comprise a tab 55 disposed on the exterior of member23. Tab 55 may be positioned on the circumference of member 23 at aposition generally opposite to member 25 and may be oriented on member23 to extend generally axially. Tab 55 may be shaped to include atransverse opening 57.

Access device 13 may also comprise a cannula or sheath 61 (see FIGS.2(a)-2(c)). Sheath 61, shown in FIGS. 4(a) and 4(b), may comprise aunitary structure, preferably made of a medical-grade polymer or asimilarly suitable material having columnar strength as well as angularflexibility. Sheath 61, which may be a tubular member having alongitudinal channel 62, may be shaped to include a proximal portion61-1, a distal portion 61-2, and an intermediate portion 61-3. Proximalportion 61-1, which may have a frusto-conical shape tapering inwardlyfrom an open proximal end 63, may be fixedly secured by adhesive orother suitable means to the hub 21. This can be at the interior ofmember 23 along wall 35 of the hub 21, with the remainder of sheath 61extending distally therefrom. Distal portion 61-2 may have a wallthickness that tapers distally to a distal end 64. Sheath 61 may beappropriately dimensioned so that the exposed portion of sheath 61,i.e., the portion of sheath 61 that extends distally from hub 21, has alength that is slightly greater than the length of a typical femalehuman urethra and additionally has an external diameter that permits theexposed portion of sheath 61 to easily traverse a typical female humanurethra. For illustrative purposes, sheath 61 may have a length ofapproximately 4.1 in and an external diameter of about 24 Fr.

Access device 13 may further comprise a handle 71 (see FIGS. 2(a)-2(c)).Handle 71, shown in FIGS. 5(a) through 5(c), may comprise a pair ofidentical, nearly identical, or simply corresponding handle halves 73-1and 73-2, each of which may be a unitary structure preferably made of ahard, medical-grade polymer or a similarly suitable material. Half 73-1(which is also shown separately in FIG. 6) and half 73-2 may be securedto one another by suitable means (e.g., adhesive, welding, etc.) to forma tubular structure having a longitudinal channel 75 and comprising aproximal portion 77-1 of comparatively greater diameter, a distalportion 77-2 of comparatively lesser diameter, and an intermediateportion 77-3 of intermediate diameter. Proximal portion 77-1, which maybe generally cylindrical in shape, may include a proximal end 79 havingan opening 81 and an internal circumferential ridge 83 (seen best inFIG. 6) spaced distally a short distance from proximal end 79. Distalportion 77-2, which may be generally cylindrical in shape, may beappropriately dimensioned for insertion into proximal portion 32-1 ofhub 21 and may include external helical threads 85 adapted to engagethread 33. In this manner, distal portion 77-2 of handle 71 may bescrewed into proximal portion 32-1 of hub 21. (A sealing ring 86, shownin FIG. 2(b), which may be made of silicone or a similarly suitablematerial, may be inserted around distal portion 77-2 of handle 71 forproviding a seal between hub 21 and handle 71.) Intermediate portion77-3 may have an exterior surface 87 that is appropriately contoured topermit being held by a person, for example, using two fingers of onehand. Intermediate portion 77-3 may additionally include a pair of axialribs 89-1 and 89-2, which may be used to receive therebetween a proximalend 55-1 of tab 55 and, thereby, limit rotation of handle 71 relative tohub 21.

Access device 13 may further comprise a valve assembly 91 (see FIGS.2(b)-2(c)), which may be disposed within handle 71. Any of a number ofdifferent valve assemblies can be used. Valve assembly 91, shown inFIGS. 7(a) and 7(b), may comprise a unitary structure, preferably madeof a medical-grade silicone or a similarly suitable material. Valveassembly 91 may be shaped to include a proximal portion 92-1, a distalportion 92-2, and an intermediate portion 92-3. Proximal portion 92-1may be a generally tubular structure shaped to include a proximal end93, a distal end 95, and a circular side wall 97. Proximal end 93 may beshaped to include a central opening 93-1 leading to a longitudinalchannel 94 extending from proximal end 93 to distal end 95. Channel 94may include a proximal section 94-1, an intermediate section 94-2, and adistal section 94-3, with intermediate section 94-2 having acomparatively greater diameter, with distal section 94-3 having acomparatively lesser diameter, and with proximal section 94-1 having anintermediate diameter. Distal portion 92-2 of valve assembly 91 may be agenerally tubular structure shaped to include a proximal end 101, adistal end 103, and a circular side wall 105. Distal end 103 may have acentral opening 103-1 leading to a longitudinal channel 107 extendingfrom proximal end 101 to distal end 103. Intermediate portion 92-3 ofvalve assembly 91 may be a generally tubular structure shaped to includea proximal end 111, a distal end 113, and a side wall 115. Side wall 115may be appropriately shaped to define a proximal valve 117 and a distalvalve 119. Valves 117 and 119 may divide the interior of intermediateportion 92-3 into a proximal channel 118 that is in fluid communicationwith distal section 94-3 of proximal portion 92-1 and a distal channel120 that is in fluid communication with channel 107 of distal portion92-2. Valves 117 and 119, each of which may be a four-sided duckbillvalve, may be oriented in opposite directions relative to one another,with valve 117 tapering in a distal direction and with valve 119tapering in a proximal direction. Moreover, the distal end of valve 117and the proximal end of valve 119 may be conjoined so that valves 117and 119 open and close in unison. As will be discussed further below,valves 117 and 119 may be constructed so as to be biased towards aclosed state. While in such a closed state, valves 117 and 119 may serveto prevent fluids or other matter from passing through valve assembly91. In particular, because of its distally-tapered orientation, valve117 may serve to prevent fluid from flowing proximally through valveassembly 91. In addition, as will also be discussed further below,valves 117 and 119 may be opened, when desired, by inserting anappropriate medical device through valve assembly 91. A benefit of theopposed orientation of valve 119 relative to valve 117 is that valve 119may reduce the likelihood that, as a medical device that has previouslybeen inserted through valve assembly 91 is thereafter withdrawn fromvalve assembly 91, valve 117 will scrape against the exterior of themedical device being withdrawn. Such scraping may be undesirable, forexample, where the medical device is a removal device used to remove apressure-attenuating device from a patient and the scraping causes thepressure-attenuating device to become detached from the removal device.

Referring now to FIG. 8(a), there is shown a side view, partly incross-section, of the combined handle 71 and valve assembly 91. As canbe seen, distal portion 92-2 of valve assembly 91 may be dimensionedrelative to the interior surface of intermediate portion 77-3 of handle71 such that a gap 121 may be provided therebetween. Without wishing tobe limited to any particular theory of operation, the present inventorsbelieve that gap 121 may be advantageous in permitting a portion of thefluid entering handle 71 through distal portion 77-2 to flow proximallyaround distal portion 92-2 and to accumulate around the exterior ofintermediate portion 92-3 of valve 91. Such accumulated fluid may serveto equalize the fluid pressures within intermediate portion 92-3 ofvalve assembly 91 and around the exterior of intermediate portion 92-3of valve assembly 91, thereby promoting the biasing of valves 117 and119 to a normally closed state. According to one embodiment, gap 121 maybe sized to be approximately 0.0001-2 inches, preferably about0.001-0.500 inch, more preferably about 0.010-0.050 inch.

As can also be seen in FIG. 8(a), proximal portion 92-1 of valveassembly 91 may be dimensioned relative to proximal portion 77-1 ofhandle 71 such that proximal portion 92-1 may form a fluid-tight sealwith ridge 83. In this manner, fluid flowing proximally through gap 121may be kept from flowing proximally past ridge 83. As can be seen inFIG. 8(b), a structure, such as an O-ring 122 may be added around valveassembly 91 to help valves 117 and 119 coapt without relying on cavitypressure. In some embodiments, the valve assembly 91 can be madetogether with or as part of the handle 71.

Referring now to FIGS. 2(b)-2(c) and 9(a)-9(b), access device 13 mayfurther comprise a seal 125. Seal 125 may comprise a unitary structure,which may be made of a medical-grade silicone or a similarly suitablematerial. Seal 125 may be of annular shape having a central opening 126.Seal 125 may be appropriately dimensioned to be mounted within valveassembly 91 as shown in FIG. 2(c). Seal 125 may be positioned in valveassembly 91 in intermediate section 94-2 of channel 94, with a rearsurface 125-1 of seal 125 fixed by suitable means (e.g., ultrasonicwelding, adhesive, etc.) to a shelf 126 (see FIG. 7(b)) within valveassembly 91. Central opening 126 may be appropriately dimensioned toform a fluid-tight seal coaxially around a medical device (e.g.,delivery device 15, removal device 19, etc.) that has been insertedthrough valve assembly 91. In this manner, if valves 117 and 119 areopened by such a medical device inserted through valve assembly 91, seal125 may serve to minimize the proximal leakage of fluid around saidmedical device.

Access device 13 may further comprise a dilator or obturator 131 (seeFIGS. 2(b)-2(c)). Obturator 131, shown in FIGS. 10(a) and 10(b), maycomprise a unitary structure, preferably made of a medical-grade polymeror a similarly suitable material having columnar strength as well asangular flexibility. Obturator 131, which may be a tubular member havinga cavity or channel 132, may be shaped to include a proximal portion133-1, a distal portion 133-2, and an intermediate portion 133-3. Itshould be understood that, although obturator 131 is shown in thepresent embodiment as having a longitudinal channel, such a channel neednot be a longitudinal channel and, alternatively, could be a channel, atleast portion of which does not extend along the longitudinal axis ofobturator 131. For example, channel 132 could have a proximal openingand/or a distal opening that is positioned on the side of obturator 131,or obturator 131 could simply have one opening, such as in the case of apocket or cavity located at or near the distal end of the obturator.

Referring to FIG. 10(a)-10(b), each of proximal portion 133-1, distalportion 133-2, and intermediate portion 133-3 may be generallycylindrical in shape, with proximal portion 133-1 and distal portion133-2 having similar outer diameters over much of their respectivelengths and with intermediate portion 133-3 having a narrowed outerdiameter as compared to that of proximal portion 133-1 and distalportion 133-2. Distal portion 133-2 may include a frusto-conical distalend 135 that may be formed, in part, by a wall thickness that tapersdistally. Channel 132, which may extend from a proximal end 137 ofobturator 131 to distal end 135, may be narrowed within intermediateportion 133-3, as well as in the adjacent portions of proximal portion133-1 and distal portion 133-2, and also may be narrowed as itapproaches distal end 135.

Obturator 131 may be appropriately dimensioned so as to permit itsdistal end 135 to be inserted coaxially through the combination of seal125, valve assembly 91, tubular member 23, and sheath 61, with distalend 135 of obturator 131 extending a short distance distally beyonddistal end 64 of sheath 61, with proximal end 137 of obturator 131extending a short distance proximally of proximal end 63 of sheath 61,with proximal portion 133-1 possibly but not necessarily forming afluid-tight seal with seal 125, and with intermediate portion 133-3residing within valves 117 and 119 of valve assembly 91 (FIG. 2(c)).Intermediate portion 133-3 preferably has a narrowed diameter so as notto open valves 117 and 119 any more than is minimally needed.Intermediate portion 133-3 may have a length l₁ of approximately 0.001-3inches, preferably approximately 0.050-2 inches, and even morepreferably about 0.050-1 inch.

Access device 13 may further comprise an obturator handle 151 (see FIGS.2(a)-2(c)). Handle 151, shown in FIGS. 11(a) and 11(b), may comprise aunitary structure, preferably made of a hard, medical-grade polymer or asimilarly suitable material. Handle 151 may be a tubular member shapedto include a side wall 153, a proximal end 155, and a distal end 157. Alongitudinal channel 159 may extend from proximal end 155 to distal end157. Channel 159 may include a proximal portion 159-1, a distal portion159-2, and an intermediate portion 159-3. Proximal portion 159-1 anddistal portion 159-2 may have generally similar diameters to one anotherwhereas intermediate portion 159-3 may have a reduced diameter relativeto proximal portion 159-1 and distal portion 159-2. Distal portion 159-2may be appropriately dimensioned to receive proximal portion 133-1 ofobturator 131, with proximal end 137 of obturator 131 being positionedflush against a proximal end 160 of distal portion 159-2. Obturator 131may be secured to handle 151 by suitable means, such as ultrasonicwelding. To facilitate digital manipulation of handle 151 by a user, theexterior surface of handle 151 may be appropriately shaped with a pairof opposing contoured faces 163 (of which only one is shown) and with apair of opposing ribbed faces 165-1 and 165-2.

Access device 13 may further comprise a handle plug 171 (see FIGS.2(a)-2(c)). Plug 171, shown in FIGS. 12(a) and 12(b), may comprise aunitary structure, preferably made of a hard, medical-grade polymer or asimilarly suitable material. Plug 171 may be shaped to include a baseportion 173 and a barbed stem portion 175. Base portion 173 may beappropriately dimensioned to matingly fit within proximal portion 159-1of handle 151.

Barbed stem portion 175 may be appropriately dimensioned to frictionallyfit within proximal portion 133-1 of obturator 131 and to form afluid-tight seal therewith to prevent fluid flow proximally throughproximal end 137 of obturator 131. (Alternatively, plug 171 could beprovided with a narrow longitudinal bore to allow some fluid to flowproximally through proximal end 137 of obturator 131, for example, inorder to alert a user that obturator 131 has been inserted to aparticular location or depth.) In addition to preventing such proximalfluid flow through obturator 131, plug 171 may also serve to providesome mechanical strength to the joint between handle 151 and obturator131.

Access device 13 may further comprise a protective sleeve 181 (see FIGS.2(a)-2(c)). Sleeve 181, shown in FIGS. 13(a) and 13(b), may comprise atubular structure preferably comprising a flexible material, such aspolytetrafluoroethylene (PTFE) or a similarly suitable material. As willbe discussed further below, at least a portion of sleeve 181 may bepositioned within channel 132 of obturator 131, and the material used tomake sleeve 181 may additionally be lubricious (and/or channel 132 mayhave a lubricious surface in contact with the sleeve 181) in order toassist in the deployment of sleeve 181 from channel 132 in the manner tobe described further below. Sleeve 181 may comprise a first end 183, asecond end 185, and a longitudinal channel 187 extending from first end183 to second end 185. Sleeve 181 may be shaped to include a firstportion 182-1 of comparatively greater diameter and a second portion182-2 of comparatively lesser diameter. As will be described furtherbelow, sleeve 181 may be used to coaxially cover what would otherwise bethe exposed lengths of obturator 131 and sheath 61 passing through ananatomical structure, such as the urethra of a patient, with sleeve 181lining the inside walls of the anatomical structure, such as theurethra. In so doing, sleeve 181 may facilitate the insertion ofobturator 131 and sheath 61 through the anatomical structure by reducingthe shear force with the walls of the anatomical structure. Moreover,where access device 13 is used, for example, to provide access to thebladder through the urethra, sleeve 181 additionally may serve tominimize the transport of microorganisms into the urethra or bladder ofthe patient.

Information relating to materials and methods that may be used to formsleeve 181 may be found in the following patents and patentapplications, all of which are incorporated herein by reference: U.S.Pat. No. 7,255,687, Huang et al., issued Aug. 14, 2007; U.S. Pat. No.6,240,968, Bigonzi-Jaker et al., issued Jun. 5, 2001; U.S. Pat. No.6,007,488, Jaker et al., issued Dec. 28, 1999; U.S. Pat. No. 5,897,535,Feliziani et al., issued Apr. 27, 1999; U.S. Pat. No. 5,711,841, Jaker,issued Jan. 27, 1998; U.S. Pat. No. 5,676,688, Jaker et al., issued Oct.14, 1997; U.S. Pat. No. 5,531,717, Roberto et al., issued Jul. 2, 1996;U.S. Patent Application Publication No. US 2008/0015518, Huang et al.,published Jan. 17, 2008; U.S. Patent Application Publication No. US2005/0197627, Huang et al., published Sep. 8, 2005; German Patent No. DE692 25 599 T2, published Jan. 28, 1999; and European Patent No. 0 605427 B1, published May 20, 1998.

It is to be understood that although sleeve 181 has been describedherein as being a tubular structure, sleeve 181 could alternatively beprovided in the form of one or more flat sheets.

Referring back to FIGS. 2(a) and 2(c), access device 13 may furthercomprise a slide ring assembly 191 coaxially mounted around sheath 61.Slide ring assembly 191 may comprise an inner member 193, an outermember 195, and an O-ring 197 illustrated in FIG. 2(b). Inner member193, shown in detail in FIGS. 14(a) and 14(b), may comprise a unitarystructure, preferably made of a hard, medical-grade polymer or asimilarly suitable material. Inner member 193 may be a tubular structureshaped to include a proximal portion 199 and a distal portion 201.Proximal portion 199 may include a continuous side wall 203 defining aproximal end 205 and a longitudinal channel 207. One or more transverseslots 204 may be provided in side wall 203, and one or more ribs 206 maybe arranged along an exterior circumference of side wall 203. Distalportion 201 may include a generally circular side wall 209 defining adistal end 211 and a longitudinal channel 213. A generally circulargroove 212 may be formed on the exterior surface of side wall 209 at itsproximal end, and one or more ribs 214 may be arranged along an exteriorcircumference of side wall 209 at a location intermediate to groove 212and distal end 211. Channels 207 and 213 may be collinearly aligned withone another, with channel 213 having a comparatively lesser diameter andwith channel 207 having a comparatively greater diameter. Channel 213may be appropriately dimensioned to permit member 193 to be freely slidover sheath 61 in the manner to be discussed further below. Channel 207may be appropriately dimensioned to permit proximal portion 199 toreversibly snap-lock onto the exterior of distal portion 32-2 of hub 21by engaging circumferential rib 37. One or more internal axial ribs 215may be provided on the interior surface of wall 203 to delimit rotationof proximal portion 199 on distal portion 32-2 of hub 21 by abutting oneor more of ribs 41 and 43 on distal portion 32-2.

Outer member 195, shown in FIGS. 15(a) and 15(b), may comprise a unitarystructure, preferably made of a hard, medical-grade polymer or asimilarly suitable material. Outer member 195 may be a tubular structureshaped to include a continuous side wall 221 defining a proximal end223, a distal end 225 and a longitudinal channel 227 extending fromproximal end 223 to distal end 225. Proximal end 223 and longitudinalchannel 227 may be appropriately dimensioned to receive inner member193, which may be fixedly secured to outer member 195 by suitable means.O-ring 197 (FIG. 16) may be appropriately constructed to mate tightlywith groove 212 of inner member 193.

Side wall 221 of the outer member 195 may have a generally tapered shapeto facilitate digital manipulation by a user, with proximal end 223having a comparatively greater diameter than distal end 225.(Alternatively, distal end 225 could have a comparatively greaterdiameter than proximal end 223.) One or more circumferential ribs 229,which may facilitate gripping, may be provided on the exterior of sidewall 221.

Moving now to FIGS. 17(a)-17(b), the assembled slide ring assembly 191can be seen together with other components of the system. The slide ringassembly 191 can engage and secure one end of the sleeve. As can be seenbest in FIGS. 17(a) and 17(b), first portion 182-1 of sleeve 181 may betightly secured between O-ring 197 and inner member 193, with secondportion 182-2 of sleeve 181 extending distally through distal end 225 ofouter member 195. By securing sleeve 181 to inner member 193 in thismanner, sleeve 181 may be mechanically coupled to sliding ring assembly191 for sliding movement therewith relative to sheath 61. Consequently,as seen in FIG. 17(a), when ring assembly 191 is in its initial distalposition, a length of second portion 182-2 of sleeve 181 may serve tocover the portion of obturator 131 that is located distal to ringassembly 191, with the remainder of second portion 182-2 of sleeve 181wrapping around distal end 135 of obturator 131 and being tucked intochannel 132 of obturator 131.

Thereafter, as ring assembly 191 may be slid proximally relative tosheath 61, the length of second portion 182-2 of sleeve 181 residingwithin channel 132 of obturator 131 may be withdrawn from withinobturator 131 through distal end 135 and may be everted, or pulledoutward and inside out, over obturator 131 and sheath 61 until theentirety of sleeve 181 has been withdrawn from channel 132. As can beseen in FIG. 17(b), when ring assembly 191 is in its most proximalposition, distal end 185 of sleeve 181 may be positioned proximal todistal end 65 of sheath 61, thereby exposing the distal ends of sheath61 and obturator 131. Nonetheless, sleeve 181 preferably has anappropriate length so that, for example, where access device 13 is usedto provide access to the bladder through the urethra, the distal ends ofsheath 61 and obturator 131 may be covered by sleeve 181 as the distalends of sheath 61 and obturator 131 pass through the urethra of apatient. In some embodiments, the ring assembly 191 is maintained inposition, while the rest of the access device is advanced distally.

To position distal end 185 of sleeve 181 within channel 132 of obturator131, one may, prior to the insertion of plug 171 into obturator handle151, insert a device having a distal loop (not shown) distally throughobturator handle 151, through obturator 131, and through distal end 185of sleeve 181, then thread distal end 185 of sleeve 181 through thedistal loop of the inserted device, and then retract the inserteddevice, with sleeve 181 attached thereto, until distal end 185 of sleeve181 is located within channel 132, the device thereafter detaching fromsleeve 181 after its continued withdrawal. In positioning distal end 185of sleeve 181 within obturator 131 in the aforementioned manner, thelength of second portion 182-2 of sleeve 181 positioned within channel132 of obturator 131 may not necessarily lie flat against the interiorsurface of obturator 131, but such an occurrence should be of noconsequence.

Referring back now to FIGS. 2(a) through 2(c), access device 13 mayfurther comprise one or more restraining mechanisms for limiting distaland/or proximal sliding movement of slide ring assembly 191 relative tosheath 61. As can be appreciated, absent such a restraint, slide ringassembly 191 may be free to slide relative to sheath 61. Consequently,if access device 13 is held in such a way that sheath 61 is pointeddownwardly, assembly 191 may slide distally relative to sheath 61, evenpossibly sliding entirely off of sheath 61. Such a decoupling ofassembly 191 from sheath 61 would be highly undesirable since, amongstother things, it may preclude keeping the distal ends of sheath 61 andobturator 131 covered by sleeve 181 until after the distal ends ofsheath 61 and obturator 131 have passed through the urethra or otherdesired anatomical structure of a patient. Further, the slide ringassembly 191 may be inadvertently slid proximally on sheath 61, eitherall the way to hub 21 or substantially all the way to hub 21. Suchproximal movement of assembly 191 would be highly undesirable since,amongst other things, it could cause end 185 of sleeve 181 to beprematurely withdrawn from obturator 131, which, in turn, may precludekeeping the distal ends of sheath 61 and obturator 131 covered by sleeve181 until after the distal ends of sheath 61 and obturator 131 havepassed through the urethra or other desired anatomical structure of apatient. Though two separate restraining mechanisms are disclosedherein, it will be understood that a single restraining mechanism couldalso perform the functions of both.

One of the two restraining mechanisms may comprise a tether 241. Tether241 may be a string, suture, band, or a similarly suitable structure.The tether 241 may comprise an elongated member having a proximal end243 and a distal end 245 (FIG. 18). Proximal end 243 may be secured tohub 21, for example, by being looped through opening 57 and tied to tab55. Distal end 245 may be secured to slide ring assembly 191, forexample, through an interference-fit by being inserted between innermember 193 and outer member 195. Therefore, because tether 241 issecured at one end to hub 21 and at the opposite end to ring assembly191 and because tether 241 is sized appropriately in length, distalmovement of assembly 191 relative to sheath 61 may be restricted and, inparticular, assembly 191 may be restrained from moving beyond a desiredaxial position on sheath 61.

The other of the two restraining mechanisms may comprise a retainingcard 261. Card 261, shown in FIGS. 19(a) through 19(c), may comprise aunitary structure, preferably made of a rigid cardstock, polymer, or asimilarly suitable material. Card 261 may be cut and scored from a sheetof suitable material to define a top portion 263, a left flap 265extending downwardly a short distance from a left side of top portion263, and a right flap 267 extending downwardly a short distance from aright side of top portion 263. Top portion 263 may have a width that mayexceed the diameter of sheath 61. In this manner, with top portion 263positioned over sheath 61, left flap 265 may be positioned on one sideof sheath 61 and right flap 267 may be positioned on the opposite sideof sheath 261. A proximal end 263-1 of top portion 263 may be shaped toinclude a recess 269 that may be appropriately dimensioned to matinglyengage waist 53 of tubular member 25. A distal end 263-2 of top portion263 may be appropriately dimensioned to engage slide ring assembly 191and may be shaped to include a tab 271 that may be inserted into innermember 193 of assembly 191. In this manner, with recess 269 engagingwaist 53 and with tab 271 inserted into inner member 193 of assembly191, retaining card 261 may be used to prevent proximal movement ofassembly 191 relative to sheath 61. Card 261 may also serve to preventrotation of slide ring assembly 191 relative to sheath 61 and, in sodoing, may limit the extent to which sleeve 181 may become twistedwithin obturator 131. Such a twisting of sleeve 181 within obturator 131may be undesirable as it may increase the resistance of sleeve 181 toevert properly when such eversion is eventually desired. Card 261 ispreferably removed from device 13 when proximal movement of assembly 191relative to sheath 61 is desired. Preferably, card 261 is removedimmediately before insertion of the distal end of device 13 into apatient (although card 261 could alternatively be removed afterinsertion of the distal end of device 13 into a patient). To facilitatethe removal of card 261, top portion 263 may be shaped to include a tab275 connected via a living hinge 277 at a proximal end of tab 275. Tab275 may be marked, either through direct printing or via an adhesivelabel, with an arrow 278 or similar indicia to indicate that tab 275 maybe pulled distally to disengage waist 53 from recess 269. Thereafter,tab 271 may be removed from inner member 193.

Access device 13 may further comprise a fluid extension line 281 (seeFIGS. 2(a)-2(c)). Line 281, which may be a unitary tubular structurepreferably made from a medical-grade polymer or a similarly suitablematerial, may comprise a proximal end 283 and a distal end 285. Astopcock valve 287, which may be a three-way stopcock valve, may becoupled to proximal end 283 of line 281 and may also be coupled to afluid source (not shown) and to a drain (not shown). A male luerconnector 289, which may be connectable to second tubular member 25 ofhub 21, may be coupled to distal end 285 of line 281. Where accessdevice 13 is used to provide access to a urinary bladder, thecombination of line 281, stopcock valve 287, and connector 289 may beused, after obturator 131 has been removed, to deliver fluids to thepatient's bladder or to drain fluids from the patient's bladder. As canbe appreciated, one advantage to the aforementioned combination of line281, stopcock valve 287, and connector 289 is that, where stopcock valve287 is being operated to drain fluid from the patient's bladder, suchurine may be collected from a patient at a location remote from thepatient's meatus.

Prior to use, access device 13 may be sterilized by a suitablesterilization technique, for example, ethylene oxide treatment.

Referring now to FIGS. 20A-B, there are shown two flowcharts,schematically depicting possible methods 290A and 290, respectively, ofusing access device 13 to provide access to a desired anatomicalstructure. Such access can be, for example, trans-urethral access to afemale human urinary bladder. Method 290A may begin with a step 290-1Aof unlocking a restraining mechanism. This can be done, for example, byremoving card 261 from device 13, preferably by pulling tab 275 distallyuntil waist 53 of hub 21 disengages from recess 269 of tab 275 and thenby removing tab 271 from inner member 193 of slide ring assembly 191(see FIG. 21(a)). Method 290A may then continue with a step 290-2A ofaligning and inserting the distal end of the access device into a body.This can include positioning a meatal stop next to the meatus. This mayalso include aligning and inserting distal end 135 of obturator 131 intothe outer opening of the urethra, with the distal end of slide ringassembly 191 contacting the meatus of the patient and with distal end135 of obturator 131 being covered by sleeve 181 (see FIG. 21(b) withthe urethra being represented by the reference letter U, the meatusbeing represented by the reference letter M, and the bladder beingrepresented by the reference letter B). Though illustratedschematically, in some embodiments, the slide ring assembly 191 canengage the body tissue at the meatus. Method 290 may then continue witha step 290-3 of advancing obturator 131 and sheath 61 distally throughthe urethra U in a straight and steady motion until sleeve 181 evertscompletely (is pulled outward and turned inside out) and slide ringassembly 191 snaps onto the distal end of hub 21 (see FIG. 21(c)). (Withobturator 131 and sheath 61 advanced in the manner discussed above,distal end 135 of obturator 131 and distal end 64 of sheath 61 may bepositioned within the bladder B of a patient.) Preferably, as obturator131 and sheath 61 are advanced distally in the manner discussed above,rotation of obturator 131 and sheath 61 relative to slide ring assembly191 is avoided so as to minimize twisting of sleeve 181, which twistingmay impede eversion of sleeve 181.

Method 290 may then proceed to step 290-4 of withdrawing obturator 131proximally from sheath 61, hub 21, and handle 71 by holding hub 21stationary with one hand while grasping and pulling on obturator handle151 with the other hand (see FIG. 21(d)). With obturator 131 thusremoved, the remaining implanted portion of access device 13 may providea conduit through which medical devices, such as delivery device 15,pressure-attenuating device 17, and removal device 19, may be deliveredto a desired anatomical structure. During the above-recited steps,stopcock valve 287 may be either opened or closed, depending upon thedesign of the access device and whether or not one wishes to allow fluidfrom the patient's bladder to empty. In some embodiments, the obturator131 can block access to the fluid extension line 281 and the stopcockvalve 287. Thus, fluid may be drained after the access sheath ispositioned and the obturator 131 removed.

As has been mentioned, other access devices or systems can be used. Theaccess sheath can vary from a basic cannula to any number of differentcombinations involving at least some of the access sheath componentsdescribed herein.

As noted above, it may be desirable to minimize the rotation of slidering assembly 191 relative to obturator 131 and sheath 61 so as tominimize the twisting of sleeve 181 within obturator 131. Although card261 may satisfactorily prevent such rotation prior to its removal fromaccess device 13, once card 261 has been removed from access device 13,there may be no remaining mechanism in access device 13 for restrainingsuch rotation. Therefore, according to one aspect, certain alternateembodiments are disclosed below that may include a rotation-restrainingmechanism.

Referring now to FIGS. 22(a) through 22(c), there are shown variousviews of a first alternate embodiment of an access device 301. Accessdevice 301 may be similar in most respects to access device 13, theprincipal difference between the two devices being that access device301 may further include a mechanism for restraining rotational movementof the slide ring assembly relative to the sheath and the obturator inthe absence of a retaining card. In the present embodiment, saidmechanism may include a sheath 303 and an inner ring member 305. Sheath303 and inner ring member 305 may be similar in most respects to sheath61 and inner ring member 193, respectively, of device 13. A principaldifference between sheath 61 and sheath 303 may be that sheath 303 mayadditionally include a pair of axially-extending grooves 306-1 and 306-2provided in a side wall 307 at approximately opposing points along thecircumference of side wall 307. A principal difference between innerring member 193 and inner ring member 305 may be that inner ring member305 may additionally include a pair of tongues 309-1 and 309-2 extendingradially inwardly from a side wall 311, tongues 309-1 and 309-2 beingappropriately positioned and appropriately dimensioned to mate with andto travel within grooves 306-1 and 306-2, respectively, in such a way asto restrain rotational movement of inner ring member 305 relative tosheath 61. It will be understood that the tongue and groove can beswitched to be on opposite components from that described above. Inaddition, there may be one or more tongues and grooves.

Referring now to FIG. 23, there is shown an enlarged fragmentarylongitudinal section view of a second alternate embodiment of an accessdevice 321. Access device 321 may be similar in most respects to accessdevice 301. A principal difference between the two devices may be thataccess device 321 may comprise barbs 325-1 and 325-2, instead of tongues309-1 and 309-2 that mate with and are angled distally within grooves306-1 and 306-2, respectively. The aforementioned arrangement of barbs325-1 and 325-2 and grooves 306-1 and 306-2, respectively, can restrainfacile distal movement of inner ring member 323 relative to sheath 303and can restrain rotational movement of inner ring member 323 relativeto sheath 303 but permits facile proximal movement of inner ring member323 relative to sheath 303. It may be noted that, because theaforementioned arrangement restrains facile distal movement of innerring member 323 relative to sheath 303, access device 321 need notadditionally include tether 241.

Referring now to FIG. 24, there is shown an enlarged fragmentarylongitudinal section view of a third alternate embodiment of an accessdevice 341. Access device 341 may be similar in most respects to accessdevice 321, but may be devoid of grooves. As can be appreciated,although the aforementioned arrangement of access device 341 mayrestrain facile distal movement of inner ring member 323 relative tosheath 343 while permitting facile proximal movement of inner ringmember 323 relative to sheath 343, this arrangement does not provide anyrestraint of rotational movement of inner ring member 323 relative tosheath 343.

Referring now to FIG. 25, there is shown an enlarged fragmentarylongitudinal section view of a fourth alternate embodiment of an accessdevice 361. Access device 361 may be similar in most respects to accessdevice 301, but, instead of having a pair of tongues 309-1 and 309-2,access device 361 may comprise one or more one-way rollers. Two one-wayrollers 365-1 and 365-2 can be coupled to inner ring member 363 anddisposed within grooves 306-1 and 306-2, respectively, in such a manneras to permit facile proximal movement of inner ring member 363 relativeto sheath 303 while restraining facile distal movement and facilerotational movement of inner ring member 363 relative to sheath 303.

Referring now to FIGS. 26 and 27, there are shown top and enlargedfragmentary perspective views, respectively, of a fifth alternateembodiment of an access device 371. Access device 371 can comprise ahousing assembly, a sheath assembly, and a fluid control system. Accessdevice 371 may be similar in certain respects to access device 13. Onedifference between the two access devices may be that, whereas accessdevice 13 may include hub 21 and handle 71, access device 371 mayinstead include a housing 373. Housing 373 may be a generallywing-shaped structure including a proximal end 374-1, which may becomparatively wider, and a distal end 374-2, which may be comparativelynarrower. Housing 373 may comprise a first housing portion 375 and asecond housing portion 377. Each of first housing portion 375 and secondhousing portion 377 may be made of a hard, medical-grade polymer or asimilarly suitable material. First housing portion 375 and secondhousing portion 377 may be joined together by screws (not shown) orother suitable means.

Preferably, housing 373 of access device 371 is dimensioned to have agreater length, as measured from proximal end 374-1 to distal end 374-2,than the corresponding length of the combination of hub 21 and handle 71of access device 13. Due in part to such an increased length, accessdevice 371 may enable an operator to keep his hands farther away from apatient than may be the case with access device 13. This may bedesirable insofar as it may improve patient comfort and may reduce thelikelihood of urinary tract infections resulting from the operatorcontacting the patient's anatomy and then cross-contaminating accessdevice 371 and/or tools inserted through access device 371.

Another difference between access device 371 and access device 13 may bethat, whereas access device 13 may comprise a single stopcock valve 287,which may be a three-way stopcock valve, access device 371 may insteadcomprise a pair of stopcock valves 381 and 383, each of which may be atwo-way stopcock valve. Valve 381, which may be mounted in first housingportion 375, may be used to control the flow of fluid through a firstport 385 disposed on one side of proximal end 374-1 of housing 373.Valve 383, which may be mounted in first housing portion 375, may beused to control the flow of fluid through a second port 387 disposed onanother side of proximal end 374-1 of housing 373. One of ports 385 and387 may be connected, for example, to a fluid source so that fluid maybe delivered to the patient, and the other of ports 385 and 387 may beconnected, for example, to a drain or similar fluid collection device sothat fluid may be drained from the patient.

Due in part to the design of housing 373 and the placement of stopcockvalves 381 and 383 relative to housing 373, an operator may hold accessdevice 371 and may operate stopcocks 381 and 383 using only one hand.This is in contrast with access device 13, where for most operators atleast one hand may be needed to hold handle 71 and another hand may beneeded to operate stopcock 287. The fact that access device 371 may beheld and operated with a single hand may be desirable as it may reducethe likelihood of cross-contamination, as well as simplifying fluidcontrol.

Still another difference between access device 371 and access device 13may be that, whereas device 13 may comprise a slide ring assembly 191and one or more restraining mechanisms 241 and 261, device 371 mayinstead comprise a slide assembly 391 and a ratchet track 393. Slideassembly 391 may comprise a slide 395, which may be a tubular membermade of a hard, medical-grade polymer or similarly suitable material.Slide 395, which may be coaxially mounted over sheath 61, may be shapedto include a proximal end 397 and a distal end 399. Proximal end 397 maybe shaped to include a pair of spring clips 401 substantially evenlyspaced on the outer circumference of slide 395. Distal end 399 may be inthe shape of an outwardly-extending circumferential flange. Distal end399 may be used to engage slide 395 so that slide 395 may be slidrelative to sheath 61. (Such sliding may be effected either by grippingdistal end 399 in one hand and manually sliding slide 395 proximallyover sheath 61 or, more preferably, by pressing distal end 399 againstthe patient and using the patient's body, such as the patient's meatus,to cause slide 395 to slide proximally over sheath 61.) Slide assembly391 may further comprise a mechanism (not shown) disposed within slide395 proximate to distal end 399 for retaining the proximal end ofprotective sleeve 181.

Ratchet track 393 may comprise a pair of rails 394-1 and 394-2. Rails394-1 and 394-2, which may be integrally formed with second housingportion 377 and disposed within the interior of housing 373, may bearranged parallel to one another and may be positioned so as to be onopposite sides of sheath 61 and slide 395. Rails 394-1 and 394-2 may bedimensioned and positioned so that spring clips 401 may slide thereoveras slide 395 is moved proximally. A plurality of detents 405 may beformed on rails 394-1 and 394-2.

Detents 405 may be shaped to permit facile proximal movement of clips401 over detents 405 but to prevent facile distal movement of clips 401over detents 405. In this manner, slide assembly 391 may be effectivelypermitted to move only proximally, with distal and rotational movementbeing constrained by ratchet track 393. As can be appreciated, thenumber and spacing of detents 405 on rails 394-1 and 394-2 may bemodified as desired. For example, detents 405 may be positioned atregular or irregular intervals along the entire length of travel ofslide assembly 391 or may be positioned at regular or irregularintervals only at a latter part of the length of travel of slideassembly 391.

As can be appreciated, access device 371 may be shaped so that thoseportions thereof that may come into contact with the patient, suchportions including, for example, distal end 399 of slide 395 and/ordistal end 374-2 of housing 373, may be relatively smooth, with aminimal number of sharp edges. In this manner, irritation of the patientcaused by contact with access device 371 may be minimized.

Although access device 371 is shown without an obturator, access device371 may include an obturator, such as an obturator similar to obturator131.

Referring now to FIG. 28, there is shown a top view of a sixth alternateembodiment of an access device 431. Access device 431 can comprise ahousing assembly, a sheath assembly, and a fluid control system. Accessdevice 431 may be similar in certain respects to access device 371. Onedifference between the two access devices may be that, whereas accessdevice 371 may comprise stopcock valve 381 for controlling the flow offluid through first port 385 and stopcock valve 383 for controlling theflow of fluid through second port 387, device 431 may instead comprise asingle stopcock valve 433. Stopcock valve 433 may be a three-waystopcock valve that may be used to control the flow of fluid boththrough port 385 and through port 387, for example, by having a firstposition in which port 385 is open and port 387 is closed, a secondposition in which port 387 is open and port 385 is closed, and a thirdposition in which both ports 385 and 387 are closed.

Although access device 431 is shown without an obturator, access device431 may include an obturator, such as an obturator similar to obturator131.

Referring now to FIGS. 29(a) through 29(c), there are shown top, side,and perspective views, respectively, of a seventh alternate embodimentof an access device 461. Access device 461 can comprise a housingassembly, a sheath assembly, and a fluid control system. Access device461 may be similar in certain respects to access device 431. Onedifference between the two access devices may be that, whereas accessdevice 431 may comprise stopcock 433 for controlling the flow of fluidthrough ports 385 and 387, access device 461 may instead comprise acam-actuated valve mechanism 463, extending through a slot 465 in ahousing 467, for controlling the flow of fluid through ports 385 and387.

Referring also now to FIG. 30, there is shown a simplified schematicrepresentation of a fluid control system 463 such as a cam-actuatedvalve mechanism 463. The cam-actuated valve mechanism 463 may comprise afirst compliant tube 469, a second compliant tube 471, and a cam 473.First compliant tube 469 may be connected at one end to port 385 and atan opposite end to sheath 61, and second compliant tube 471 may beconnected at one end to port 387 and at an opposite end to sheath 61.Cam 473, which may be accessible to an operator through a slot 465provided in a housing 467 of access device 461, may be used selectivelyto pinch shut or to keep open first compliant tube 469 and secondcompliant tube 471. Tubes 469 and 471 and cam 473 may be arrangedrelative to one another so that cam 473 may axially compress tubes 469and 471 positioned on the same side of cam 473. Tubes 469 and 471 may becompressed distally (away from a proximal end 467-1 of housing 467). Cam473 may be mounted coaxial to sheath 61 (see FIGS. 29(a) through 29(c)for sheath 61). Cam 473 may be designed to dependently control eachvalve, providing 3 functions: fill, drain, and closed (i.e., no flow). Afourth “flush” position may be included—where both the inlet and theoutlet are open at the same time.

Another difference between access device 461 and access device 431 maybe that access device 461 may further comprise an obturator 481 and anobturator handle 483. Obturator 481 may be similar to obturator 131.Obturator handle 483 may differ from obturator handle 151 in thatobturator handle 483 may comprise a D-ring. The non-circular shape of aD-ring may enable a user alternately to rest his thumb inside the D-ringduring insertion of access device 461 into a patient and to accommodatehis forefinger being inserted through the D-ring to facilitate removalof obturator 481 from the patient.

It should be understood that access device 461 could include, instead ofobturator handle 483, an obturator handle like obturator handle 151.Alternatively, access device 461 could simply not include an obturatoror obturator handle.

Referring now to FIG. 31, there is shown a simplified schematicrepresentation of a fluid control system 501 such as a first alternateembodiment of a cam-actuated valve mechanism 501. Cam-actuated valvemechanism 501, which may be a dependent-control, double-sided,axially-compressing mechanism, may comprise a first compliant tube 503,a second compliant tube 505, and a cam 507. As can be seen, firstcompliant tube 503 and second compliant tube 505 may be positioned onopposite sides of cam 507 in cam-actuated valve mechanism 501.

Referring now to FIGS. 32(a) through 32(d), there are shown simplifiedschematic representations of a fluid control system 531 such as a secondalternate embodiment of a cam-actuated valve mechanism 531. Cam-actuatedvalve mechanism 531 may include a first compliant tube 533, a secondcompliant tube 535, a first cam 537, and a second cam 539. First cam 537may be used to pinch shut first compliant tube 533, and second cam 539may be used to pinch shut second compliant tube 535. First cam 537 andsecond cam 539 may be independently operable. In this manner,cam-actuated valve mechanism 531 may be operated to assume any one of a“closed” position as shown in FIG. 32(a), a “fill” position as shown inFIG. 32(b), a “drain” position as shown in FIG. 32(c), and a “flush”position as shown in FIG. 32(d).

Referring now to FIGS. 33(a) through 33(c), there are shown simplifiedschematic representations of a fluid control system 571 such as a thirdalternate embodiment of a cam-actuated valve mechanism 571. Cam-actuatedvalve mechanism 571 may include a first compliant tube 573, a secondcompliant tube 575, and a linear cam 577. Linear cam 577 may be used topinch shut one or both of first compliant tube 573 and second complianttube 575. In this manner, cam-actuated valve mechanism 571 may beoperated to assume any one of a “closed” position as shown in FIG.33(a), a “fill” position as shown in FIG. 33(b), and a “drain” positionas shown in FIG. 33(c).

It should be appreciated that fluid control systems with a cam-actuatedvalve mechanism may operate in a radial direction, instead of in anaxial direction as disclosed above. Such a cam may be used to pinch shutthe compliant tubes towards the central axis or away from such an axis.An example of a fluid control system with a radially-compressing,cam-actuated valve mechanism is shown in FIG. 34 and is representedgenerally by reference numeral 591. Cam-actuated valve mechanism 591,which may be designed to be inwardly-compressing, may include a firstcompliant tube 593, a second compliant tube 595, and a cam 597. Anotherexample of a fluid control system with a radially-compressing,cam-actuated valve mechanism is shown in FIG. 35 and is representedgenerally by reference numeral 611. Cam-actuated valve mechanism 611,which may be designed to be outwardly-compressing, may include a firstcompliant tube 613, a second compliant tube 615, and a cam 617.

In any cam configuration, including the various cam configurationsdescribed above, the cam may be detented at a flow position to providetactile feedback that the cam is in a desired position. Also, instead ofpositioning the selector switch of the cam at the top of the housing,the switch may be located on the bottom of the housing or at any pointalong the travel of the cam. In addition, in any cam configurationdisclosed herein, the cam may be constructed to provide more than merelya “flow” position and a “no-flow” position, but rather, to additionallyinclude one or more “intermediate-flow” positions having flow ratesintermediate to that of the “no-flow” and “flow” positions.

Moreover, in the embodiments described herein, the cam face may slidedirectly across the compliant tubes. Such sliding may create anundesirable amount of friction, thereby requiring too much force to movethe cam selector switch. To reduce the friction at this interface,pushrods may be used to follow the cam face and to translate itsdisplacement into pure linear motion. Such pushrods would then pinch thecompliant tubes without shearing across them, thereby reducing theamount of friction generated.

Referring now to FIGS. 36(a) through 36(c), there are shown variousviews of an eighth alternate embodiment of an access device 721. Theaccess device 721 can comprise a housing assembly, a sheath assembly,and a fluid control system. Access device 721 may be similar in certainrespects to access device 431. One difference between the two accessdevices may be that, whereas access device 431 may include slideassembly 391 and ratchet track 393, access device 721 may include aslide assembly 723 and a pair of bosses 725. Slide assembly 723 maycomprise a slide 727, which may be a tubular member made of a hard,medical-grade polymer or a similarly suitable material. Slide 727 may beprovided with a plurality of notches 729, which may be positioned atregular intervals along substantially the entire length of travel ofslide 727. Bosses 725, which may be integrally formed on a housingportion 731 of access device 721, may be oriented to engage notches 729in such a way as to permit facile proximal movement of slide 727 whilepreventing facile distal movement of slide 727. Rotational movement ofslide 727 relative to the housing of access device 721 may beconstrained by an axially-extending rib 733 provided on the interiorsurface of housing portion 731 that may travel within a correspondingaxially-extending notch 735 on slide 727. (An additional rib may beprovided on the housing portion that is not shown, and a correspondingnotch may be provided in the portion of slide 727 that is not shown.)Slide assembly 723 may further comprise a mechanism (not shown) disposedwithin slide 727 for retaining the proximal end of the protective sleeve(not shown).

It is to be understood that, although notches 729 are disclosed above asbeing positioned at regular intervals along substantially the entirelength of slide 727, notches 729 may be positioned at irregularintervals and/or may be positioned only along a portion of the length oftravel of slide 727.

For example, referring now to FIGS. 37(a) and 37(b), there are shownvarious views of a ninth alternate embodiment of an access device 751.Access device 751 can comprise a housing assembly, a sheath assembly,and a fluid control system. Access device 751 may differ from accessdevice 721 in that, whereas access device 721 may include slide 727having notches 729 positioned at regular intervals substantially alongits entire length, access device 751 may instead include a slide 753(shown separately in FIG. 38) including only a proximal notch 755 and adistal notch 757. As seen best in FIG. 37(a), with slide 753 in itsdistal position (i.e., before insertion of access device 751 into apatient), bosses 725 may engage proximal notch 755 of slide 753.Proximal notch 755 may be shaped to provide only slight resistance tomovement of slide 753 in either axial direction. A purpose of theproximal notch 755 is to position slide 753 during assembly and to keepslide 753 in its distal position before deployment of access device 751.During insertion of access device 751 into a patient, the slide 753 canbe moved past proximal notch 755 with only slight resistance from bosses725. There may be clearance between bosses 725 and notch 755 to preventbosses 725 and slide 753 from permanently deforming at elevatedtemperatures or after extended periods of time. As slide 753 movesbetween proximal notch 755 and distal notch 757, bosses 725 may deflectand may apply light pressure to the outer diameter of slide 753 due toan interference fit. When slide 753 is in its proximal position (i.e.,upon full insertion of access device 751 into a patient), bosses 725 maysnap into distal notch 757, which may be beveled or otherwise positionedto lock bosses 725 in place.

Referring now to FIGS. 39(a) and 39(b), there are shown various views ofa tenth alternate embodiment of an access device 801. Access device 801can comprise a housing assembly, a sheath assembly, and a fluid controlsystem. Access device 801 may differ from access device 751 in that,whereas access device 721 may include slide 753, access device 801 mayinstead include a slide 803 (also shown separately in FIG. 40). Slide803 may be shaped to include a ring portion 805 and a pair of angularlydeflectable or splaying legs 807-1 and 807-2 extending from ring portion805. As seen best in FIG. 39(a), with slide 803 in its distal position(i.e., before insertion of access device 801 into a patient), feet 809-1and 809-2 at the ends of legs 807-1 and 807-2, respectively, may engagenotches 811-1 and 811-2, respectively, provided on the exterior surfaceof a sheath 813. During insertion of access device 801 into a patient,feet 809-1 and 809-2 may be easily moved proximally past notches 811-1and 811-2 with only slight resistance and may move proximally along anoutwardly-tapering track 813 formed along the inside of the housing ofaccess device 801. When slide 803 is in its proximal position (i.e.,upon full insertion of access device 803 into a patient), feet 809-1 and809-2 may engage the proximal end of track 813 in such a way as to lockslide 803 in place.

One advantage of access device 801, as compared to access devices likeaccess device 751, is that splaying legs 807-1 and 807-2 may permitaccess device 801 to have a reduced axial length.

Referring now to FIGS. 41(a) through 41(d), there are shown variousviews of an eleventh alternate embodiment of an access device 901.Access device 901 can include a housing assembly 903, a sheath assembly,and a fluid control system. The sheath assembly may include a cannula orsheath 913, a protective sleeve 925, a slide ring assembly 927, adilator or obturator 921, and an obturator handle 923. The fluid controlsystem can include a hub 905, a cam 907, a pair of compliant tubes 909-1and 909-2, a pair of fluid connectors 911-1 and 911-2, a valve assembly915, a seal 917, and a cap 919. Each of the foregoing components willnow be discussed in detail.

Referring now to FIGS. 42(a) and 42(b), housing 903 may comprise a pairof complementary housing halves 931 and 933, each of which may be aunitary structure made of a hard, medical-grade polymer or a similarlysuitable material. Housing half 931 is also shown separately in FIGS.43(a) and 43(b), and housing half 933 is also shown separately in FIGS.44(a) and 44(b). Housing halves 931 and 933 may be joined together bysuitable means, such as by screws, adhesive, or ultrasonic welding, tojointly define a generally gun-shaped structure including a barrelportion 935 and a handle portion 937.

Barrel portion 935, which may be generally circular in transversecross-section, may be a tubular structure shaped to include a proximalend 939 and a distal end 941. Barrel portion 935 may taper incross-sectional diameter from proximal end 939 to distal end 941.Proximal end 939 may be shaped to include an opening 943, and distal end941 may be shaped to include an opening 945. Acircumferentially-extending slot 947, the purpose of which will becomeapparent below, may be provided along the top surface of barrel portion935 and may be spaced distally a short distance from proximal end 939.Slot 947 may have a first end 948-1 and a second end 948-2. Indentations949 and 951, which may be used as finger rests to receive the forefingerand middle finger, respectively, of an operator, may be provided alongthe top and bottom surfaces, respectively, of barrel portion 935 at theinterface of barrel portion 935 and handle portion 937 and may be usedto facilitate the holding of housing 903 in one hand. (The thumb of thesame hand of the user may also rest on housing 903 below barrel portion935 and proximal to handle portion 937; alternatively, as will becomeapparent below, the thumb of the same hand of the user may also be usedto operate cam 907.) Rib 953 (see, for example, FIGS. 43(a) and 43(b))and rib 955 (see, for example, FIG. 44(a)), which may be formed on theinterior surfaces of housing halves 931 and 933, respectively, betweenproximal end 939 and slot 947, may be used to axially secure hub 905within housing 903. Rib 957 (see, for example, FIGS. 43(a) and 43(b))and rib 959 (see, for example, FIG. 44(a)), which may be formed on theinterior surfaces of housing halves 931 and 933, respectively, justdistal to indentations 949 and 951, may be used to rotationally securehub 905 within housing 903.

Handle portion 937, which may be generally elliptical in transversecross-section, may be a tubular structure shaped to include a joined end961 and a free end 963. Handle portion 937 may extend downwardly at anangle from barrel portion 935, with joined end 961 being joined tobarrel portion 935 at a location between slot 947 and indentations 949and 951. Free end 963 may be shaped to include an opening 965 (see, forexample, FIG. 42(b)), the purpose of which will become apparent below.Rib 967 (see, for example, FIGS. 43(a) and 43(b)) and rib 969 (see, forexample, FIG. 44(a)) may be formed on the interior surfaces of housinghalves 931 and 933, respectively, just above free end 963 and may beused, in combination with free end 963, to securely receive fluidconnectors 911-1 and 911-2, respectively.

Referring now to FIGS. 45(a) through 45(d), hub 905 may be a unitarystructure made of a hard, medical-grade polymer or a similarly suitablematerial. Hub 905 may comprise a proximal portion 971 and a distalportion 973, each of which may be generally tubular in shape. Proximalportion 971 and distal portion 973 may be coaxial with one another, withproximal portion 971 having a comparatively larger diameter and withdistal portion 973 having a comparatively smaller diameter.

Proximal portion 971 of hub 905 may comprise a proximal end 975 and adistal end 977. Proximal end 975 may be shaped to include a proximalopening 979 and a circumferential flange 981 extending radiallyoutwardly a short distance therefrom. A circumferential rib 983 may beprovided on the exterior of proximal portion 971 and may be spaceddistally a short distance from flange 981. Rib 983 and flange 981 mayjointly define a waist 985 therebetween. Waist 985 may be appropriatelydimensioned to receive rib 953 (see, for example, FIGS. 43(a) and 43(b))and rib 955 (see, for example, FIG. 44(a)) of housing 903 to axiallysecure hub 905 within housing 903. A rib 988, which may extend distallya short distance from rib 983, may be formed on the exterior of proximalportion 971. As will be discussed further below, rib 988 may be used todelimit the rotation of cam 907 relative to hub 905. A pair of tubularposts 989-1 and 989-2 may extend distally a short distance from distalend 977 of proximal portion 971. Posts 989-1 and 989-2, which may be influid communication with the interior of proximal portion 971, may beappropriately dimensioned for compliant tubes 909-1 and 909-2 (see, forexample, FIG. 41(d)), respectively, to be inserted coaxially thereoverand to be retained thereon by an interference fit.

Distal portion 973 of hub 905 may comprise a proximal end 991 and adistal end 993. Distal end 993 may be shaped to include a distal opening995 and a pair of tabs 997-1 and 997-2 extending radially outwardly ashort distance from the top and bottom surfaces, respectively, of distalportion 973. Tabs 997-1 and 997-2 may be appropriately dimensioned toengage rib 957 (see, for example, FIGS. 43(a) and 43(b)) and rib 959(see, for example, FIG. 44(a)) of housing 903 in such a way as torotationally secure hub 905 within housing 903.

Referring now to FIGS. 46(a) through 46(e), cam 907 may be a generallytubular unitary structure made of a hard, medical-grade polymer or asimilarly suitable material. Cam 907, which may be rotatably mountedover hub 905, may comprise a circular side wall 1001 having a proximalend 1003 and a distal end 1005. Side wall 1001 may be appropriatelydimensioned to coaxially receive hub 905, as well as to receivecompliant tubes 909-1 and 909-2 inserted axially therethrough. Acircumferentially-extending recess 1007 may be provided in side wall1001 proximate to proximal end 1003. Recess 1007, which may include afirst end 1009, a second end 1011, and a midpoint notch 1013, may beappropriately dimensioned to receive rib 988 of hub 905 in such a waythat rib 988 may delimit the rotation of cam 907 relative to hub 905.

Cam 907 may further comprise a handle 1015, which may extend radiallyoutwardly from side wall 1001. Handle 1015 may be appropriatelydimensioned to extend through slot 947 (see, for example, FIG. 41(a)) inhousing 903. In this manner, an operator may, for example, using histhumb, manipulate the handle 1015 to different positions within slot947, e.g., a first position in which handle 1015 is centered within slot947 (as shown, for example, in FIG. 41(a)), a second position in whichhandle 1015 is positioned at end 948-1 (as shown, for example, in FIG.47), and a third position in which handle 1015 is positioned at end948-2 (as shown, for example, in FIG. 48). Slot 947 may be appropriatelydimensioned so that (i) when handle 1015 is positioned against end 948-1of slot 947, rib 988 may be positioned against first end 1009 of recess1007, (ii) when handle 1015 is positioned against end 948-2 of slot 947,rib 988 may be positioned against second end 1011 of recess 1007, and(iii) when handle 1015 is centered within slot 947, the distal tip ofrib 988 may be positioned within notch 1013 of recess 1007.

Cam 907 may further comprise a distal wall 1017 disposed within distalend 1005 of side wall 1001. Distal wall 1017, which may be generallyU-shaped, may be appropriately dimensioned so that, depending on theangular position of cam 907, one or both of compliant tubes 909-1 and909-2 may be pinched shut between distal wall 1017 and distal portion973 of hub 905. For example, when cam 907 is angularly positioned sothat handle 1015 is centered within slot 947, distal wall 1017 may pinchshut both compliant tube 909-1 and compliant tube 909-2 against distalportion 973 of hub 905. Alternatively, when cam 907 is angularlypositioned so that handle 1015 is positioned at end 948-1 of slot 947,distal wall 1017 may pinch shut compliant tube 909-2 against distalportion 973 of hub 905 while permitting compliant tube 909-1 to remainopen, and when cam 907 is angularly positioned so that handle 1015 ispositioned at end 948-2 of slot 947, distal wall 1017 may pinch shutcompliant tube 909-1 against distal portion 973 of hub 905 whilepermitting compliant tube 909-2 to remain open.

FIGS. 49(a) through 49(c) are rear fragmentary views of access device901, with certain components, such as compliant tubes 909-1 and 909-2,not being shown for clarity. More specifically, FIG. 49(a) shows accessdevice 901 with handle 1015 of cam 907 centered within slot 947 (as inFIG. 41(a)), FIG. 49(b) shows access device 901 with handle 1015 of cam907 positioned at end 948-1 of slot 947 (as in FIG. 47), and FIG. 49(c)shows access device 901 with handle 1015 of cam 907 positioned at end948-2 of slot 947 (as in FIG. 48). As can be seen in FIG. 49(a), whenhandle 1015 of cam 907 is centered within slot 947, distal wall 1017 ispositioned so as to be substantially aligned with both post 989-1 andpost 989-2. As a result, with distal wall 1017 thus positioned,compliant tubes 909-1 and 909-2, which are not shown but are mounted onposts 989-1 and 989-2, respectively, are pinched shut between distalwall 1017 of cam 907 and distal portion 973 of hub 905. By comparison,as seen in FIG. 49(b), when handle 1015 of cam 907 is positioned at end948-1 of slot 947, distal wall 1017 is positioned so as to besubstantially aligned with post 989-2 but not with post 989-1.Consequently, with distal wall 1017 thus positioned, compliant tube909-2 is pinched shut between distal wall 1017 of cam 907 and distalportion 973 of hub 905 whereas compliant tube 909-1 is not pinched shutbetween distal wall 1017 of cam 907 and distal portion 973 of hub 905.Finally, as seen in FIG. 49(c), when handle 1015 of cam 907 ispositioned at end 948-2 of slot 947, distal wall 1017 is positioned soas to be substantially aligned with post 989-1 but not with post 989-2.As a result, with distal wall 1017 thus positioned, compliant tube 909-1is pinched shut between distal wall 1017 of cam 907 and distal portion973 of hub 905 whereas compliant tube 909-2 is not pinched shut betweendistal wall 1017 of cam 907 and distal portion 973 of hub 905.

It is to be understood that, although distal wall 1017 of cam 905 isconstructed in the present embodiment to have three positions, namely,(i) a position in which both compliant tube 909-1 and compliant tube909-2 are simultaneously pinched shut, (ii) a position in whichcompliant tube 909-1 is allowed to be open and compliant tube 909-2 ispinched shut, and (iii) a position in which compliant tube 909-1 ispinched shut and compliant tube 909-2 is allowed to be open, distal wall1017 of cam 905 may be constructed to have additional positions, such asa flush position in which both compliant tube 909-1 and compliant tube909-2 are allowed to be open. In addition, device 901 may be constructedso that each of compliant tubes 909-1 and 909-2 may not be limited tobeing placed only in either a fully opened state or a fully closedstate, but rather, may additionally be placed in a finite number or inan infinite number (i.e. continuously adjustable) of partially openedstates having flow rates varying by equal or unequal increments betweena fully opened state and a fully closed state.

Referring back now to FIG. 41(d), compliant tubes 909-1 and 909-2 eachmay be a generally tubular unitary member made of a flexiblemedical-grade silicone or a similarly suitable material. Compliant tube909-1 may include a first end 1031 and a second end 1033, and complianttube 909-2 may include a first end 1035 and a second end 1037. First end1031 of compliant tube 909-1 may be coaxially mounted over post 989-1and may be secured thereto, for example, by an interference fit or othersuitable means, and first end 1035 of compliant tube 909-2 may becoaxially mounted over post 989-2 and may be secured thereto, forexample, by an interference fit or other suitable means. In the abovemanner, compliant tubes 909-1 and 909-2 may be placed in fluidcommunication with the interior of proximal portion 971 of hub 905 and,thus, may be placed in fluid communication with the interior of sheath913 when obturator 921 is removed from sheath 913.

Second end 1033 of compliant tube 909-1 may be coaxially inserted into afirst end 1041-1 of fluid connector 911-1 and may be secured thereto,for example, by adhesive or other suitable means, and second end 1037 ofcompliant tube 909-2 may be coaxially inserted into a first end 1041-2of fluid connector 911-2 and may be secured thereto, for example, byadhesive or other suitable means. A second end 1043-1 of fluid connector911-1 may be in the shape of a female luer lock connector, and a secondend 1043-2 of fluid connector 911-2 may be in the shape of a female luerlock connector. One of fluid connectors 911-1 and 911-2 may be connectedto a male luer lock connector (not shown) that, in turn, may beconnected to a fluid source, and the other of fluid connectors 911-1 and911-2 may be connected to a male luer lock connector (not shown) that,in turn, may be connected to a drain. Consequently, one of complianttubes 909-1 and 909-2 may be used to deliver fluid to a patient, and theother of compliant tubes 909-1 and 909-2 may be used to drain fluid fromthe patient. Fluid connector 911-1 may be further shaped to include aflange 1045-1, and fluid connector 911-2 may be further shaped toinclude a flange 1045-2. Flange 1045-1 may be appropriately dimensionedto mate with housing half 931 between rib 967 (see FIGS. 43(a) and43(b)) and free end 963, thereby securing fluid connector 911-1 tohousing half 931. Similarly, flange 1045-2 may be appropriatelydimensioned to mate with housing half 933 between rib 969 (see FIG.44(a)) and free end 963, thereby securing fluid connector 911-2 tohousing half 933.

The fluid flow rates for access device 901 may be in the range of about1 cc/min to about 1000 cc/min, preferably about 10 cc/min to about 500cc/min, and more preferably about 100 cc/min to about 250 cc/min.Moreover, the following dimensions, which may affect how cam 907 pinchesshut tubes 909-1 and 909-2, may be used:

More Dimension Range Preferred Preferred Tubing OD 0.001″-5.00″0.01″-0.50″ 0.1″-0.49″ Tubing ID 0.001″-5.00″ 0.01″-0.50″ 0.05″-0.49″ Cam “Closed” Diameter 0.001″-5.00″ 0.01″-1.00″ 0.1″-0.50″ Cam “Open”Diameter 0.001″-5.00″ 0.01″-1.00″ 0.1″-0.70″ Compression Applied by0.001″-5.00″ 0.01″-1.00″ 0.05″-0.10″  Cam (stroke length) Cam Ramp Angle(each side) 0-360 0-90 0-60 degrees degrees degrees

Although not shown in the present embodiment, housing 903 may beprovided with appropriate markings proximate to slot 947 to indicate thevarious positions that handle 1015 of cam 907 may be located so thatfluid may be delivered to a patient, so that fluid may be drained from apatient, or neither. For example, to indicate a “filling” function,i.e., where fluid is to be delivered to the patient, one may use, forexample, the following indicia: “IN,” “FILL,” “+,” or an arrowindicating inflow. To indicate a “draining” function, i.e., where fluidis to be drained from the patient, one may use, for example, thefollowing indicia: “OUT,” “DRAIN,” “−,” or an arrow indicating outflow.To indicate that the device is closed for fluid transfer in eitherdirection, one may use, for example, the following indicia: “CLOSED,” acircle with a single line through it, or an “X” circumscribed with acircle. If a flush function were added, one may use, for example, thefollowing indicia: “FLUSH” or “↔.”

Referring now to FIGS. 50(a) through 50(c), sheath 913, which maycomprise a generally tubular unitary structure made of a medical-gradepolymer or a similarly suitable material having columnar strength aswell as angular flexibility, may be shaped to include a proximal portion1053-1, a distal portion 1053-2, and a longitudinal channel 1054,longitudinal channel 1054 extending through the entire respectivelengths of proximal portion 1053-1 and distal portion 1053-2. Proximalportion 1053-1, which may have a generally cylindrical shape, mayinclude a proximal end 1055, which may be fixedly secured, for example,by adhesive or other suitable means within hub 905 proximate to theinterface of proximal portion 971 and distal portion 973, with theremainder of proximal portion 1053-1 of sheath 913 extending distallytherefrom. A plurality of longitudinally-extending grooves 1057 may beprovided on the exterior of proximal portion 1053-1 of sheath 913. Aswill be discussed further below, grooves 1057, which may terminate atthe interface of proximal portion 1053-1 and distal portion 1053-2, mayserve as a track along which slide ring assembly 927 (see, for example,FIGS. 41(a) and 41(b)) may slide.

Distal portion 1053-2 of sheath 913, which may have a generallyfrusto-conical shape, may include a distal end 1059. Distal portion1053-2 may have a wall thickness that tapers distally to distal end1059.

Sheath 913 may be appropriately dimensioned so that the exposed portionof sheath 913, i.e., the portion of sheath 913 that extends distallyfrom housing 903, has a length that is slightly greater than the lengthof a typical female human urethra and additionally has an externaldiameter that permits the exposed portion of sheath 913 to easilytraverse a typical female human urethra. For illustrative purposes,sheath 913 may have an external diameter of about 24 Fr and may bedimensioned so that the length of sheath 913 inserted into the patient'surethra has a length in the range of about 0.001 inch to about 100inches, preferably about 1 inch to about 10 inches, more preferablyabout 1.5 inch to about 2 inches.

Referring now to FIGS. 41(c), 41(d), and FIG. 51, valve assembly 915,which may be similar in size, shape, construction, and function to valveassembly 91 of access device 13, may comprise a proximal portion 1071-1that may be similar to proximal portion 92-1 of valve assembly 91, adistal portion 1071-2 that may be similar to distal portion 92-2 ofvalve assembly 91, and an intermediate portion 1071-3 that may besimilar to intermediate portion 92-3 of valve assembly 91. Onedifference between valve assembly 915 and valve assembly 91 may be that,whereas proximal portion 92-1 of valve assembly 91 may be shaped forseal 125 to be mounted therewithin, valve assembly 915 may not be soshaped. Instead, seal 917, which may be similar to seal 125 but having agreater outer diameter, may have its distal surface 917-1 positionedflush against a proximal end 1072 of proximal portion 1071-1 of valveassembly 915. Valve assembly 915 may be partially coaxially insertedinto proximal portion 971 of hub 905, with a distal end 1073 of proximalportion 1071-1 of valve assembly 915 abutting proximal end 975 of hub905 and with a distal end 1075 of distal portion 1071-2 of valveassembly 915 being spaced a short distance from distal end 977 ofproximal portion 971 of hub 905 to define a gap 1080. In this manner,for example, fluid from the patient may flow proximally to gap 1080through sheath 913 (proximal end 1055 of sheath 913 being disposed justdistal to gap 1080), and such fluid may then flow from gap 1080 intoposts 989-1 and 989-2. Then, depending on the positioning of cam 907 andthe respective patencies of compliant tubes 909-1 and 909-2, such fluidmay flow through compliant tube 909-1, compliant tube 909-2 or neither.In a corresponding fashion, fluid may be delivered from compliant tube909-1 or compliant tube 909-2 to sheath 913 via gap 1080.

Referring also now to FIGS. 52(a) through 52(d), cap 919, which may be aunitary structure made of a hard, medical-grade polymer or similarlysuitable material, may comprise a proximal portion 1101 and a distalportion 1103, each of which may be generally tubular in shape. Proximalportion 1101 and distal portion 1103 may be coaxial with one another,with proximal portion 1101 being comparatively larger in diameter andwith distal portion 1103 being comparatively smaller in diameter.Proximal portion 1101 may include a proximal face 1105 and a distal face1106. An opening 1107 may be provided in proximal face 1105. Opening1107, the purpose of which will become apparent below, may be shaped toinclude a generally circular central portion 1109 and a pair of sidelobes 1111-1 and 1111-2. Cap 919 may be appropriately dimensioned sothat distal end 1106 of proximal portion 1101 may lie flush againstproximal end 939 of housing 903, with distal portion 1103 residingwithin housing 903 (see FIG. 41(c)). Cap 919 may also be appropriatelydimensioned to coaxially receive the combination of seal 917, proximalportion 1071-1 of valve assembly 915, and flange 981 of hub 905 (seeFIG. 51). Distal portion 1103 of hub 905 may be secured to flange 981 ofhub 905 by any suitable means, such as, for example, ultrasonic welding.The securing of cap 919 to hub 905 may serve not only to fasten cap 919to hub 905 but also to compress seal 917 and valve assembly 915 toensure that these components create a fluid-tight seal and to constrainthese components against axial or other movement during use of accessdevice 901.

Referring now to FIGS. 41(c), 41(d), 53, and 54, obturator 921 may besimilar in most respects to obturator 131 of access device 13. Onedifference between the two obturators may be that obturator 921 mayinclude a distal end 1121 that is more blunted than distal end 135 ofobturator 131. Such a blunted end may reduce the likelihood that thedistal end of the obturator may cause injury or discomfort to thepatient during its insertion.

Referring now to FIGS. 41(a) through 41(d), 53, 55(a) and 55(b),obturator handle 923, which may be a unitary structure made of a hard,medical-grade polymer or similarly suitable material, may comprise aproximal portion 1201, an intermediate portion 1203, and a distalportion 1205. Proximal portion 1201, which may be a generally planarmember having an hourglass profile, may be shaped to include a pair ofrecesses 1207-1 and 1207-2 at opposing locations on its periphery.Recesses 1207-1 and 1207-2 may be appropriately dimensioned toaccommodate the thumb and forefinger, respectively, of a user or theforefinger and thumb, respectively, of a user. Proximal portion 1201 maybe further shaped to include a transverse opening 1209, which may becentrally located. Intermediate portion 1203, which may be generallytubular in shape, may be concentrically positioned around opening 1209and may extend distally a short distance from proximal portion 1201.Distal portion 1205, which may be generally tubular in shape, may extenddistally a short distance from intermediate portion 1203, distal portion1205 being coaxial with but comparatively smaller in diameter thanintermediate portion 1203. Distal portion 1205 and intermediate portion1203 may be appropriately dimensioned so that a proximal end 1210 ofobturator 921 may be axially received therewithin and may be fixed tohandle 923 by suitable means. With obturator 921 thus secured to handle923, opening 1209 may be in fluid communication with the interior ofobturator 921. Consequently, where, for example, access device 901 isused to provide access to a bladder, correct placement of obturator 921in the bladder may be noted by the proximal flow of urine throughopening 1209. However, if such confirmation is unnecessary orundesirable, opening 1209 may be eliminated.

Distal portion 1205 may comprise a distal end 1211 that is mateable withopening 1107 in proximal face 1105 of cap 919. Consequently, byinserting distal end 1211 of handle 923 through opening 1107 and,thereafter, rotating handle 923 clockwise relative to cap 919 byapproximately 90 degrees, one may lock handle 923 to cap 919 and, in sodoing, may prevent unwanted axial movement of obturator 921 relative tocap 919 and, thus, relative to sheath 913. For example, such locking mayprevent undesired proximal movement of obturator 921 relative to sheath913 as obturator 921 is being inserted into a patient. After accessdevice 901 has been properly placed in a patient, obturator 921 may beremoved from the remainder of access device 901 by rotating handle 923counterclockwise relative to cap 919 until distal end 1211 of handle 923may be withdrawn through opening 1107 of cap 919.

It should be understood that a flush adapter may be used in place ofobturator 921 to provide flushing capabilities at the tip of sheath 913.It should also be understood that a multiple lumen sheath could be usedin place of sheath 913 to provide flushing capabilities. Alternatively,the end of the obturator handle may include a luer or other attachmentthat may allow for the flow of fluid through the obturator to distendthe urethra during insertion of the access device. Such an attachmentmay alternatively be used to introduce fluids or tools into the bladderthrough the obturator before the obturator is removed.

Referring now to FIGS. 41(a) through 41(d), 56(a) and 56(b), protectivesleeve 925 may be identical in size, shape, construction, and functionto protective sleeve 181 of access device 13. Protective sleeve 925 maycomprise a first end 1251 and a second end 1253. Prior to deployment ofaccess device 901, first end 1251 may be disposed within obturator 921.

Referring also now to FIG. 57, slide ring assembly 927 may comprise aninner member 1261, an outer member 1263, and an O-ring 1265. Innermember 1261, which may be a unitary structure, preferably made of ahard, medical-grade polymer or a similarly suitable material, maycomprise a tubular portion 1271. A plurality of angularly-deflectablelegs 1275 may be spaced around the periphery of tubular portion 1271 andmay extend proximally a short distance therefrom. Legs 1275 may beshaped to include feet 1276 that may lockably engage the interior ofhousing 903 once feet 1276 have been inserted into opening 945 ofhousing 903. Such locking may also provide tactile feedback that slidering assembly 927 has been fully moved to its proximal position. Aplurality of legs 1277 may be spaced around the periphery of tubularportion 1271 and may extend distally a short distance therefrom. Legs1277, which may be biased radially inwardly, may be appropriatelyconfigured and dimensioned to ride within grooves 1057 of sheath 913and, in so doing, may constrain rotational movement of inner member 1261relative to sheath 913. In addition, distal movement of inner member1261 may be constrained by the fact that grooves 1057 may terminate atthe distal end of proximal portion 1053-1 of sheath 913 and may notcontinue in distal portion 1053-2 of sheath 913. Consequently, distalportion 1053-2 of sheath 913 may effectively act as a stop for distalmovement of inner member 1261.

Second end 1253 of sleeve 925 may be inserted coaxially over tubularportion 1271 of inner member 1261 and may be secured thereto by O-ring1265. Outer member 1263, which may be a generally tubular unitary membermade of a soft or compressible medical-grade polymer or a similarlysuitable material, may be coaxially and fixedly mounted over O-ring 1265and inner member 1261. Outer member 1263, which may be shaped tominimize irritation of a patient, may include a distal flange 1281,which may be used to move slide ring assembly 927 proximally relative tosheath 913.

Access device 901 may have an overall length in the range of about 0.001inch to about 20 inches, preferably about 0.1 inch to about 10 inches,more preferably about 1 inch to about 6 inches.

Access device 901 may be used in a manner similar to that discussedabove for access device 13. For example, for trans-urethral access to afemale human urinary bladder, cam 907 may be switched to its closedposition (as in FIG. 41(a)), i.e., so that both compliant tubes 909-1and 909-2 may be pinched shut, and distal end 1121 of obturator 921 maybe aligned with and inserted into the patient. As access device 901 maycontinue to be inserted into the patient, the meatus of the patient maycause slide ring assembly 927 to be slid proximally, thereby causing theportion of sleeve 925 that is disposed within obturator 921 to beremoved therefrom and to be everted over the exterior of sheath 913,thereby providing a barrier between the patient's urethra and sheath913. Further insertion of access device 901 into the patient may causeinner member 1261 of slide ring assembly 927 to be slid proximally untilit lockably engages housing 903 (as in FIG. 57). With slide ringassembly 927 thus engaged with housing 903, the distal end of accessdevice 901 should be located in the bladder of the patient. Confirmationof such placement may be noted by the proximal flow of urine throughopening 1107 of obturator handle 923. Obturator 921 may then be removedfrom the patient by rotating obturator handle 923 until distal portion1205 of obturator handle 923 is aligned with opening 1107 of cap 919 andthen by withdrawing proximally the combination of obturator handle 923and obturator 921 from the remainder of access device 901. Withobturator 921 thus removed, the remaining implanted portion of accessdevice 901 may provide a conduit through which medical devices, such asdelivery device 15, pressure-attenuating device 17, and removal device19, may be delivered to the bladder. If desired, fluid may be deliveredto or drained from the bladder by switching cam 907 from its closedposition to one of its open positions (see FIGS. 47 and 48), wherebycompliant tube 909-1 is pinched shut and compliant tube 909-2 is allowedto be open or vice versa.

Referring now to FIGS. 58(a) through 58(d), there are shown variousviews of a twelfth alternate embodiment of an access device 1291. (Forsimplicity and clarity, one or more of the components of access device1291 may not be shown in all of FIGS. 58(a) through 58(d).) Accessdevice 1291 can include a housing assembly 1293, a sheath assembly, anda fluid control system. The sheath assembly can include a cannula orsheath 1303, a dilator or obturator 1311, an obturator handle 1313, aprotective sleeve 1315, and a slide ring assembly 1317. The fluidcontrol system can include a hub 1295, a cam 1297, a pair of complianttubes 1299-1 and 1299-2, a pair of fluid connectors 1301-1 and 1301-2, avalve assembly 1305, a seal 1307, and a cap 1309. Each of the foregoingcomponents will now be discussed further below.

Referring now to FIG. 59, housing 1293 may comprise a pair ofcomplementary housing halves 1319 and 1320, each of which may be aunitary structure made of a hard, medical-grade polymer or a similarlysuitable material. Housing half 1319 is also shown separately in FIGS.60(a) and 60(b), and housing half 1320 is also shown separately in FIGS.61(a) and 61(b). Housing halves 1319 and 1320 may be joined together bysuitable means, such as by screws, adhesive, or ultrasonic welding, tojointly define a generally gun-shaped structure including a barrelportion 1321 and a handle portion 1322.

Barrel portion 1321, which may be generally circular in transversecross-section, may be a tubular structure shaped to include a proximalend 1323 and a distal end 1324. Barrel portion 1321 may taper incross-sectional diameter from proximal end 1323 to distal end 1324.Proximal end 1323 may be shaped to include an opening 1325, and distalend 1324 may be shaped to include an opening 1326. Acircumferentially-extending slot 1327, the purpose of which will becomeapparent below, may be provided along the top surface of barrel portion1321 and may be spaced distally a short distance from proximal end 1323.Slot 1327 may have a first end 1327-1 and a second end 1327-2. A rib1328 (see, for example, FIGS. 60(a) and 60(b)) may be formed on theinterior surface of housing half 1319 between proximal end 1323 and slot1327, and a rib 1329 (see, for example, FIG. 61(b)) may be formed on theinterior surface of housing half 1320 between proximal end 1323 and slot1327. Ribs 1328 and 1329 may serve to axially secure hub 1295 withinhousing 1293. A rib 1330 (see, for example, FIGS. 60(a) and 60(b)) maybe formed on the interior surface of housing half 1319 between handleportion 1322 and distal end 1324, and a rib 1331 (see, for example, FIG.61(b)) may be formed on the interior surface of housing half 1320between handle portion 1322 and distal end 1324. Ribs 1330 and 1331 maybe used to rotationally secure hub 1295 within housing 1293.

Handle portion 1322, which may be generally elliptical in transversecross-section, may be a tubular structure shaped to include a joined end1332 and a free end 1333. Handle portion 1322 may extend downwardly atan angle from barrel portion 1321, with joined end 1332 being joined tobarrel portion 1321 at a location between slot 1327 and distal end 1324.Free end 1333 may be shaped to include an opening 1334 (see, forexample, FIGS. 60(b) and 61(b)), the purpose of which will becomeapparent below. A rib 1335 (see, for example, FIGS. 60(a) and 60(b)) maybe formed on the interior surface of housing half 1319, and a rib 1336(see, for example, FIG. 61(b)) may be formed on the interior surface ofhousing half 1320. Ribs 1335 and 1336 may be used, in combination withfree end 1333, to securely receive fluid connectors 1301-1 and 1301-2,respectively. A first plurality of ribs 1337 (see, for example, FIGS.60(a) and 60(b)) may be formed on the interior surface of housing half1319 between rib 1335 and barrel portion 1321, and a second plurality ofribs 1338 (see, for example, FIG. 61(b)) may be formed on the interiorsurface of housing half 1320 between rib 1336 and barrel portion 1321.Ribs 1337 and 1338 may be used to form channels for receiving complianttubes 1299-1 and 1299-2.

Referring now to FIGS. 62(a) and 62(b), hub 1295 may be a unitarystructure made of a hard, medical-grade polymer or a similarly suitablematerial. Hub 1295 may comprise a proximal portion 1339 and a distalportion 1340, each of which may be generally tubular in shape. Proximalportion 1339 and distal portion 1340 may be coaxial and in fluidcommunication with one another, with proximal portion 1339 having acomparatively larger inner diameter and with distal portion 1340 havinga comparatively smaller inner diameter.

Proximal portion 1339 of hub 1295 may comprise a proximal end 1341 and adistal end 1342. Proximal end 1341 may be shaped to include a proximalopening 1343. A pair of circumferential ribs 1344 and 1345 may beprovided on the exterior of proximal portion 1339 and may be spaceddistally a short distance from proximal end 1341. Ribs 1344 and 1345 mayjointly define a waist 1346 therebetween. Waist 1346 may beappropriately dimensioned to receive rib 1335 (see, for example, FIGS.60(a) and 60(b)) and rib 1336 (see, for example, FIG. 61(b)) of housing1293 to axially secure hub 1295 within housing 1293. The interior ofproximal portion 1339 of hub 1295 may be appropriately dimensioned tocoaxially receive valve assembly 1305.

Distal portion 1340 of hub 1295 may comprise a proximal end 1347 and adistal end 1348. Distal end 1348 may be shaped to include a distalopening 1349 and a pair of tabs 1350-1 and 1350-2 extending radiallyoutwardly a short distance from the top and bottom surfaces,respectively, of distal portion 1340. Tabs 1350-1 and 1350-2 may beappropriately dimensioned to engage rib 1330 (see, for example, FIGS.60(a) and 60(b)) and rib 1331 (see, for example, FIG. 61(a)) of housing1293 in such a way as to rotationally secure hub 1295 within housing1293. A pair of tubular posts 1351-1 and 1351-2 may extend downwardlyfrom the bottom of distal portion 1340. Post 1351-1 may be positionedproximate to proximal end 1347 of distal portion 1340, and post 1351-2may be spaced distally a short distance from post 1351-1. Posts 1351-1and 1351-2, which may be in fluid communication with the interior ofdistal portion 1340, may be appropriately dimensioned for complianttubes 1299-1 and 1299-2 (see, for example, FIG. 58(d)), respectively, tobe inserted coaxially thereover and to be retained thereon by aninterference fit.

Referring now to FIGS. 63(a) through 63(c), cam 1297 may be a generallytubular, unitary structure made of a hard, medical-grade polymer or asimilarly suitable material. Cam 1297, which may be rotatably mountedover hub 1295, may comprise a curved side wall 1352 having an openproximal end 1353 and an open distal end 1354. A wedge-shaped slot1352-1 may be provided on the bottom surface of side wall 1352 and mayextend from proximal end 1353 to a short distance proximal to distal end1354. A first cam surface 1355 may extend distally a short distance fromdistal end 1354, and a second cam surface 1356 may extend proximally ashort distance from distal end 1354.

Cam surface 1355 may be appropriately contoured and dimensioned tocontrol fluid flow through compliant tube 1299-2, and cam surface 1356may be appropriately contoured and dimensioned to control fluid flowthrough compliant tube 1299-1. More specifically, cam surface 1355 mayinclude a ramp portion 1357, a plateau portion 1358, and a detent 1359,and cam surface 1356 may include a ramp portion 1360, a plateau portion1361, and a detent 1362. As will become apparent below, as cam 1297 isrotated in one direction, thereby effectively causing compliant tube1299-2 to ride along cam surface 1355 in the direction of detent 1359,the patency of compliant tube 1299-2 may be reduced by ramp portion 1357and may be completely closed by plateau portion 1358. Similarly, as cam1297 is rotated in an opposite direction, thereby effectively causingcompliant tube 1299-1 to ride along cam surface 1356 in the direction ofdetent 1362, the patency of compliant tube 1299-1 may be reduced by rampportion 1360 and may be completely closed by plateau portion 1361.Detent 1359 may be used to provide some resistance to the movement ofcompliant tube 1299-2 relative to cam surface 1355 as compliant tube1299-1 rides along ramp portion 1360 of cam surface 1356, and detent1362 may be used to provide some resistance to the movement of complianttube 1299-1 relative to cam surface 1356 as compliant tube 1299-2 ridesalong ramp portion 1357 of cam surface 1355. As seen best in FIG. 63(b),ramp surfaces 1355 and 1356 may have symmetrically opposing contours. Inthis manner, cam surface 1355 may be arranged to provide patency forcompliant tube 1299-2 at the same time that cam surface 1356 may preventpatency for compliant tube 1299-1, and cam surface 1356 may be arrangedto provide patency for compliant tube 1299-1 at the same time that camsurface 1355 may prevent patency for compliant tube 1299-2.

Cam 1297 may further comprise a handle 1363, which may extend upwardlyfrom the top of side wall 1352. Handle 1363 may be appropriatelydimensioned to extend through slot 1327 (see, for example, FIG. 58(a))in housing 1293. In this manner, an operator may, for example, using histhumb, slide handle 1363 to any one of three different positions withinslot 1327, i.e., a first position in which handle 1363 is centeredwithin slot 1327 (as shown, for example, in FIG. 58(a)), a secondposition in which handle 1363 is positioned at end 1327-1 (as shown, forexample, in FIG. 64), and a third position in which handle 1363 ispositioned at end 1327-2 (as shown, for example, in FIG. 65).

FIGS. 66(a) and 66(b) are bottom and perspective views, respectively, ofthe combination of hub 1295, cam 1297, and compliant tubes 1299-1 and1299-2 of access device 1291, with cam 1297 being rotated relative tohub 1295 so that handle 1363 faces directly upwardly. As can be seenbest in FIG. 66(a), in this angular orientation, compliant tube 1299-2is closed off by plateau portion 1358 of cam surface 1355, and complianttube 1299-1 is closed off by plateau portion 1361 of cam surface 1356.

FIGS. 67(a) through 67(c) are bottom views of the combination of hub1295, cam 1297, compliant tubes 1299-1 and 1299-2, sheath 1303, andslide ring assembly 1317 of access device 1291. FIG. 67(a) shows cam1297 in its closed position, with compliant tube 1299-2 being closed offby cam surface 1355 and with compliant tube 1299-1 being closed off bycam surface 1356. FIG. 67(b) shows cam 1297 rotated relative to hub 1295so that compliant tube 1299-1 is no longer closed off by cam surface1356 whereas compliant tube 1299-2 is still closed off by cam surface1355. FIG. 67(c) shows cam 1297 rotated relative to hub 1295 in theopposite direction to that shown in FIG. 67(b) so that compliant tube1299-1 is now closed off by cam surface 1356 whereas compliant tube1299-2 is no longer closed off by cam surface 1355.

It is to be understood that, although cam 1297 is constructed in thepresent embodiment to have three positions, namely, (i) a position inwhich both compliant tube 1299-1 and compliant tube 1299-2 aresimultaneously pinched shut, (ii) a position in which compliant tube1299-1 is allowed to be open and compliant tube 1299-2 is pinched shut,and (iii) a position in which compliant tube 1299-1 is pinched shut andcompliant tube 1299-2 is allowed to be open, cam 1297 may be constructedto have additional positions, such as a flush position in which bothcompliant tube 1299-1 and compliant tube 1299-2 are allowed to be open.In addition, device 1291 may be constructed so that each of complianttubes 1299-1 and 1299-2 may not be limited to being placed only ineither a fully opened state or a fully closed state, but rather, mayadditionally be placed in a finite number or in an infinite number (i.e.continuously adjustable) of partially opened states having flow ratesvarying by equal or unequal increments between a fully opened state anda fully closed state.

Referring back now to FIG. 58(d), compliant tubes 1299-1 and 1299-2 eachmay be a generally tubular unitary member made of a flexiblemedical-grade silicone or a similarly suitable material. Compliant tube1299-1 may include a first end 1364 and a second end 1365, and complianttube 1299-2 may include a first end 1366 and a second end 1367. Firstend 1364 of compliant tube 1299-1 may be coaxially mounted over post1351-1 and may be secured thereto, for example, by an interference fitor other suitable means, and first end 1366 of compliant tube 1299-2 maybe coaxially mounted over post 1351-2 and may be secured thereto, forexample, by an interference fit or other suitable means. In the abovemanner, compliant tubes 1299-1 and 1299-2 may be placed in fluidcommunication with the interior of distal portion 1340 of hub 1295 and,thus, may be placed in fluid communication with the interior of sheath1303.

Second end 1365 of compliant tube 1299-1 may be coaxially inserted intoa first end 1368-1 of fluid connector 1301-1 and may be secured thereto,for example, by adhesive or other suitable means, and second end 1367 ofcompliant tube 1299-2 may be coaxially inserted into a first end 1368-2of fluid connector 1301-2 and may be secured thereto, for example, byadhesive or other suitable means. A second end 1369-1 of fluid connector1301-1 may be in the shape of a female luer lock connector, and a secondend 1369-2 of fluid connector 1301-2 may be in the shape of a femaleluer lock connector. One of fluid connectors 1301-1 and 1301-2 may beconnected to a male luer lock connector (not shown) that, in turn, maybe connected to a fluid source, and the other of fluid connectors 1301-1and 1301-2 may be connected to a male luer lock connector (not shown)that, in turn, may be connected to a drain. Consequently, one ofcompliant tubes 1301-1 and 1301-2 may be used to deliver fluid to apatient, and the other of compliant tubes 1301-1 and 1301-2 may be usedto drain fluid from the patient. Fluid connector 1301-1 may be furthershaped to include a flange 1370-1, and fluid connector 1301-2 may befurther shaped to include a flange 1370-2. Flanges 1370-1 and 1370-2 maybe appropriately dimensioned to mate with rib 1335 of housing half 1319(see, for example, FIGS. 60(a) and 60(b)) and with rib 1336 of housinghalf 1320 (see, for example, FIG. 61(b)) to secure fluid connectors1301-1 and 1301-2 to housing 1293.

It is believed that, because compliant tubes 1299-1 and 1299-2 may besupported within the channels defined by ribs 1337 and 1338, complianttubes 1299-1 and 1299-2 may be less likely to kink, particularly whensubjected to the action of cam 1297.

The fluid flow rates for access device 1291 may be in the range of about1 cc/min to about 1000 cc/min, preferably about 10 cc/min to about 500cc/min, and more preferably about 100 cc/min to about 300 cc/min, andthe inlet pressure for access device 1291 may be in the range of, forexample, 0.01 inH₂O to 1000 inH₂O (0.0254 cmH₂O to 2540 cmH₂O),preferably 1.0 inH₂O to 100 inH₂O (2.54 cmH₂O to 254 cmH₂O), and morepreferably 20 inH₂O to 50 inH₂O (50.8 cmH₂O to 127 cmH₂O). The tubinginner diameter for compliant tubes 1299-1 and 1299-2 may be similar tothat for tubes 909-1 and 909-2 of device 901.

Housing 1293 may be provided with markings similar to those discussedabove in connection with housing 903 for indicating the variouspositions in which handle 1363 of cam 1297 may be placed so that device1291 may be used for filling, draining, flushing, or the like.

Referring back now to FIGS. 58(d), sheath 1303, valve assembly 1305,seal 1307, and protective sleeve 1315 may be identical to sheath 913,valve assembly 915, seal 917, and protective sleeve 925, respectively,of device 901.

Cap 1309, which may be shown separately in FIGS. 68(a) through 68(c),may be a unitary member structure made of a hard, medical-grade polymeror similarly suitable material. Cap 1309 may comprise a proximal portion1371 and a distal portion 1372, each of which may be generally tubularin shape. Proximal portion 1371 and distal portion 1372 may be coaxialwith one another, with proximal portion 1371 being comparatively largerin diameter and with distal portion 1372 being comparatively smaller indiameter. Proximal portion 1371 may include a proximal face 1373 and adistal face 1374. An opening 1375 may be provided in proximal face 1373.Distal portion 1372 may include a proximal end 1376 and a distal end1377. An annular wall 1378 may be provided within distal end 1377 ofdistal portion 1372. A circumferential rib 1379 may be provided aroundthe exterior of distal portion 137. Rib 1379 may be used to provide aninterference fit with a groove 1380 provided on the interior of hub 1295(see FIG. 62(b)) so that cap 1309 may be joined to hub 1295.

The combination of obturator 1311 and obturator handle 1313 is shown inFIG. 69. As can be seen, obturator 1311 may be identical to obturator921 of device 901. Obturator handle 1313, which may be shown separatelyin FIGS. 70(a) and 70(b), may be fixed to obturator 1311 and may beshaped to include spring tabs 1382 that may be inserted through opening1325 of housing 1293 (see, for example, FIGS. 60(b) and 61(b)) and thenlocked in place within housing 1293 by being rotated approximately 90degrees against a cam 1381 (see, for example, FIGS. 60(b) and 61(b)).Such locking of obturator handle 1313 to housing 1293 may preventundesired proximal movement of obturator 1311 relative to housing 1293as obturator 1311 is being inserted into a patient. After access device1291 has been properly placed in a patient, obturator 1311 may beremoved from the remainder of access device 1291 by rotating obturatorhandle 1313 counterclockwise until spring tabs 1382 are no longerengaged by cam 1381, thereby enabling obturator handle 1313 to bewithdrawn from housing 1293.

Referring now to FIGS. 71(a) and 71(b), there are shown various views ofa first alternate obturator handle 1383 to obturator handle 1313.Obturator handle 1383 may differ from obturator handle 1313 in thatobturator handle 1383 may include threaded tabs 1383-1 and 1383-2, asopposed to spring tabs 1382. Handle 1383 may be particularly well-suitedfor use with a housing having a complementarily threaded proximalopening. (See, for example, FIG. 72, which shows left housing half 1384with a threaded proximal opening 1384-1.) Handle 1383 may also differfrom handle 1313 in that handle 1383 may be shaped to include a largepocket 1383-3 and inner pockets 1383-4 and 1383-5. Large pocket 1383-3may have a uniform wall thickness, for example, to facilitate itsmanufacture by injection molding. Inner pockets 1383-4 and 1383-5 mayhave a reduced wall thickness, for example, to enable better securing ofobturator 1311 to obturator handle 1383, for example, by welding.

Referring now to FIG. 73, there is shown the combination of sheath 1303,protective sleeve 1315, and slide ring assembly 1317. Slide ringassembly 1317 may comprise an inner member 1385, an outer member 1386,and an O-ring 1387. Inner member 1385, which may be a unitary structure,preferably made of a hard, medical-grade polymer or a similarly suitablematerial, may comprise a tubular portion 1388. A circumferential notch1389 may be provided in tubular portion 1388 near a proximal end 1388-1of tubular portion 1388. Notch 1389 may be used to matingly receive apair of deflectable fins 1390 provided on the interior of housing 1293and spaced proximally a short distance from opening 1326 (see, forexample, FIG. 74). The mating of fins 1390 to notch 1389 may be used tolimit proximal movement of inner member 1385 and to provide a tactileindication to a user that inner member 1385 has been moved fully to itsproximal position. A plurality of angularly-deflectable legs 1391 may bespaced around the periphery of tubular portion 1388 and may extenddistally a short distance therefrom. Legs 1391, which may be biasedradially inwardly, may be appropriately configured and dimensioned toride within grooves 1392 of sheath 1303 and, in so doing, may constrainrotational movement of inner member 1385 relative to sheath 1303 (see,for example, FIG. 75).

An end 1315-1 of sleeve 1315 may be inserted coaxially over tubularportion 1388 of inner member 1385 and may be secured thereto by O-ring1387. Outer member 1386, which may be a generally tubular unitary membermade of a soft or compressible medical-grade polymer or a similarlysuitable material, may be coaxially and fixedly mounted over O-ring 1387and inner member 1385. Outer member 1386, which may be shaped tominimize irritation of a patient, may include a distal flange 1393,which may be used to move slide ring assembly 1317 proximally relativeto sheath 1313.

Access device 1291 may have an overall length in the range of about0.001 inch to about 20 inches, preferably about 0.1 inch to about 10inches, more preferably about 1 inch to about 6 inches.

Access device 1291 may be used in a manner similar to that discussedabove for access device 13. For example, for trans-urethral access to afemale human urinary bladder, cam 1297 may be switched to its closedposition (as in FIG. 58(a)), i.e., so that both compliant tubes 1299-1and 1299-2 may be pinched shut, and the distal end of obturator 1311 maybe aligned with and inserted into the patient. As access device 1291 maycontinue to be inserted into the patient, the meatus of the patient maycause slide ring assembly 1317 to be slid proximally, thereby causingthe portion of sleeve 1315 that is disposed within obturator 1311 to beremoved therefrom and to be everted over the exterior of sheath 1303,thereby providing a barrier between the patient's urethra and sheath1303. Further insertion of access device 1291 into the patient may causeinner member 1385 of slide ring assembly 1317 to be slid proximallyuntil it lockably engages fins 1390. With slide ring assembly 1317 thusengaged with fins 1390, the distal end of access device 1291 should belocated in the bladder of the patient. Confirmation of such placementmay be noted by the proximal flow of urine through an opening inobturator handle 1313. Obturator 1311 may then be removed from thepatient by rotating obturator handle 1313 until it disengages from cam1381 and then by withdrawing proximally the combination of obturatorhandle 1313 and obturator 1311 from the remainder of access device 1291.With obturator 1311 thus removed, the remaining implanted portion ofaccess device 1291 may provide a conduit through which medical devices,such as delivery device 15, pressure-attenuating device 17, and removaldevice 19, may be delivered to the bladder. If desired, fluid may bedelivered to or drained from the bladder by switching cam 1297 from itsclosed position to one of its open positions (see FIGS. 64 and 65),whereby compliant tube 1299-1 is pinched shut and compliant tube 1299-2is allowed to be open or vice versa.

Referring now to FIG. 76, there is shown a perspective view of a firstalternate cam 1395 for use in device 1291. Cam 1395 may differ from cam1297 in that cam 1395 may have a longer ramp portion 1396 than that ofcam 1297. In this manner, cam 1395 may be used to provide one or morestates of partial patency. Additionally, the shape of the cam allows thebody of the shell (or housing containing the cam/tubes/hub/sheath) to benarrower than if a constant radius arc (or circle) were used. Thevariable radius that is imparted onto the two cam surfaces (relative tothe axis of rotation) can provide beneficial changes in force throughoutthe rotational travel of the lever or user interface (i.e., higher rampforce, when the cam surface is transitioning from smaller radius tolarger radius).

Referring now to FIGS. 77(a) and 77(b), there are shown perspective andpartly exploded perspective views, respectively, of a second alternatecam 1397. Cam 1397 may include a first cam surface 1398-1 and a secondcam surface 1398-2, each of which may be capable of being operatedindependently of the other. Such independent operation may be enabled byremoving a block 1399 that may be used to couple handles 1400-1 and1400-2 for rotating surfaces 1398-1 and 1398-2, respectively. Byindependently operating cam surfaces 1398-1 and 1398-2, it may bepossible for device 1291 to be used for “fill,” “drain,” “flush,” and“off” functions.

Delivery Device

A delivery device may be inserted through the passageway created by theaccess device. The delivery device may be used to deliver apressure-attenuating device to the body, such as to the bladder. Thedelivery device may deliver the pressure-attenuating device in acompacted state which may then be inflated and released. The steps ofinflation and/or release may be performed by the delivery device. Thedelivery device can include a delivery tube, an inflation tube, aconnection to inflation media and a release mechanism, among otherfeatures.

Certain embodiments of a delivery device are described in U.S. PatentApplication Publication No. 2010/0222802, incorporated by referenceherein. See for example: FIGS. 6-18H, and the accompanying discussion,including at paragraphs [0153]-[0206]. Embodiments of a delivery deviceare also provided in U.S. Pat. No. 6,976,950, incorporated by referenceherein. See for example: FIGS. 6-11A, 34A-35B and 48A-48D, and theaccompanying discussion, including at columns 13-16, and 35.

Referring now to FIGS. 78(a), 78(b), 79, and 80, delivery device 15 maycomprise a housing 1401. Housing 1401, in turn, may comprise a pair ofcomplementary housing halves 1403-1 and 1403-2, housing half 1403-1 alsobeing shown separately in FIGS. 81(a) and 81(b) and housing half 1403-2also being shown separately in FIGS. 82(a) and 82(b). Each of housinghalves 1403-1 and 1403-2 may comprise a unitary structure preferablymade of a hard, medical-grade polymer or a similarly suitable material.Housing halves 1403-1 and 1403-2, which may be aligned with one anotherby pins 1405 extending from half 1403-1 and complementary sockets 1407provided in half 1403-2, may be secured to one another by suitablemeans, such as by adhesive or by ultrasonic welding. Halves 1403-1 and1403-2 may be appropriately shaped to jointly define a generally hollow,gun-shaped structure comprising a barrel portion 1409 and a handleportion 1411.

The housing 1401 may include one or more openings at the proximal end.The housing 1401 may be shaped to include a first opening 1413 at aproximal end 1415 of barrel portion 1409, a second opening 1417 spacedinwardly a short distance from first opening 1413, and a third opening1419 at a distal end 1421 of barrel portion 1409. For reasons to becomeapparent below, first opening 1413 may be of greater diameter thansecond opening 1417, and each of openings 1413 and 1417 may be angleddownwardly slightly relative to the longitudinal axis of barrel portion1409, with opening 1417 being angled downwardly to a greater extent thanis opening 1415.

Delivery device 15 may further comprise a fluid connector 1423 (seeFIGS. 79-80). Connector 1423, shown separately in FIG. 83, may bedisposed within housing 1401 and may be fixedly mounted on a pair ofsupports 1425-1 and 1427-1 formed on half 1403-2. (Complementarysupports 1425-2 and 1427-2 on half 1403-1 may be provided to furnishadditional support to connector 1423.) The connector can receive one,two, or more lines in and can have one line out. Connector 1423, whichmay be a unitary structure preferably made from a hard, medical-gradepolymer or a similarly suitable material, may be shaped to include aproximal portion 1426 of comparatively greater width and a distalportion 1428 of comparatively lesser width. A pair of fluid channels1429-1 and 1429-2 may be provided in proximal portion 1426 and mayextend in a generally parallel fashion distally from a proximal end 1431of proximal portion 1426. A fluid channel 1433 may be provided in distalportion 1428 and may extend proximally from a distal end 1435 of distalportion 1428. The distal ends of channels 1429-1 and 1429-2 may bejoined to the proximal end of channel 1433 such that each of channels1429-1 and 1429-2 may be in fluid communication with channel 1433.

Delivery device 15 may further comprise a pair of connectors and/orcheck valves 1441 and 1443 (FIGS. 79-80). The connectors and/or checkvalves can be identical or different. Though the connectors and/or checkvalves will be described generally as check valves, it will beunderstood that a check valve is not required. Check valve 1441, shownin FIG. 84, may be disposed within barrel portion 1409 and may befixedly mounted on a pair of supports 1445-1 and 1447-1 formed on half1403-2. (Complementary supports 1445-2 and 1447-2 on half 1403-1 may beprovided to furnish additional support to valve 1441.) Valve 1441, whichmay be made, for example, of a hard, medical-grade polymer or asimilarly suitable material, may comprise a proximal end 1449 and adistal end 1451. Proximal end 1449, which may be in the shape of afemale luer connector, may be oriented coaxially with opening 1413 butspaced distally a short distance therefrom. Distal end 1451 may befluidly connected to fluid channel 1429-1 of connector 1423 by a fluidline 1453. Check valve 1443 may be disposed within barrel portion 1409and may be fixedly mounted on a pair of supports 1455-1 and 1457-1formed on half 1403-2. (Complementary supports 1455-2 and 1457-2 on half1403-1 may be provided to furnish additional support to valve 1443.)Valve 1443 may comprise a proximal end 1459 and a distal end 1461.Proximal end 1459 may be oriented coaxially with opening 1417 but spaceddistally a short distance therefrom. Distal end 1461 may be fluidlyconnected to fluid channel 1429-2 of connector 1423 by a fluid line1463.

Delivery device 15 may further comprise an inflation tube 1471 (FIGS.79-80). Tube 1471, which is also shown separately in FIG. 85, may be aunitary structure preferably made of a medical-grade stainless steel ora similarly suitable material. Tube 1471 may comprise a circular sidewall 1473 defining a proximal end 1475, a distal end 1477, and alongitudinal channel 1479 extending from proximal end 1475 to distal end1477. Proximal end 1475 of tube 1471 may be fixedly mounted withinchannel 1433 of connector 1423 in such a way that channels 1433 and 1479are aligned and in fluid communication with one another. The remainderof tube 1471 may extend distally from connector 1423 through opening1419 of housing 1401, with distal end 1477 of tube 1471 being positioneda distance, e.g., several inches, from distal end 1421 of housing 1401.As will be discussed further below, distal end 1477 of inflation tube1471 may be inserted into pressure-attenuating device 17 for use ininflating device 17; therefore, inflation tube 1471, or at least thedistal end, may have an outer diameter that is appropriately dimensionedfor this purpose.

It should be understood that, although inflation tube 1471 of thepresent embodiment has a single channel 1479, inflation tube 1471 couldhave two or more such channels, with said two or more channels beingfluidly coupled to channel 1433. Alternatively, one or more of suchchannels could be fluidly coupled to connector and/or check valve 1441,and one or more of such channels could be fluidly coupled to connectorand/or check valve 1443. In this manner, for example, the materialspassing through connector and/or check valve 1441 could be conducted toone of said two or more channels, and the materials passing throughconnector and/or check valve 1443 could be conducted to another of saidtwo or more channels.

Delivery device 15 may further comprise a carriage 1491 and a decouplingor push-off member 1521 (FIGS. 79-80). These components can be part of arelease mechanism used to decouple the inflated implant from theinflation tube 1471 as will be described below. Carriage 1491, shown inFIGS. 86(a) through 86(e), may be a unitary structure preferably made ofa hard, medical-grade polymer or a similarly suitable material. Carriage1491 may be shaped to comprise a top 1493, a bottom 1495, a left side1497, a right side 1499, a proximal end 1501, and a distal end 1503.There may be one or more slots and complimentary protrusions or ribs oneither the carriage or the housing. For example, left side 1497 may beshaped to include a longitudinal slot 1505, and right side 1499 may beshaped to include a similar longitudinal slot 1507. Slot 1505 may beappropriately dimensioned to permit carriage 1491 to slide on acomplementarily shaped rib 1506 formed on half 1403-2 and extending inthe direction of the longitudinal axis of barrel portion 1409. Slot 1507may be appropriately dimensioned to permit carriage 1491 to slide on acorresponding rib 1508 formed on half 1403-1. Left side 1497 mayadditionally be shaped to include a post 1509 extending towards half1403-1, the purpose of post 1509 to become apparent below. Carriage 1491may be additionally shaped to include a longitudinal channel 1511extending from proximal end 1501 to distal end 1503. Longitudinalchannel 1511 may be aligned with and may be appropriately dimensionedrelative to inflation tube 1471 such that carriage 1491 may be permittedto ride freely along a portion of inflation tube 1471. For reasons tobecome apparent below, channel 1511 may include a proximal portion1511-1 of comparatively lesser diameter and a distal portion 1511-2 ofcomparatively greater diameter.

Push-off member 1521, shown in FIG. 87, may comprise a unitary structurepreferably made of a medical-grade polymer or a similarly suitablematerial. Push-off member 1521 may comprise a tube with a circular sidewall 1523 defining a proximal end 1525, a distal end 1527, and alongitudinal channel 1529 extending from proximal end 1525 to distal end1527. Proximal end 1525 of push-off member 1521 may be fixedly mountedby glue or other suitable means within distal portion 1511-2 of channel1511, with the remainder of push-off member 1521 extending distally fromcarriage 1491 and through opening 1419 of housing 1401. Member 1521 maybe mounted coaxially around tube 1471, and the inner diameter ofpush-off member 1521 may be sufficiently larger than the outer diameterof tube 1471 to permit member 1521 to slide freely over tube 1471.Push-off member 1521 may have a length such that, when push-off member1521 is positioned in its most proximal position, distal end 1527 ofpush-off member 1521 may be positioned sufficiently proximal to distalend 1477 of tube 1471 so as not to interfere with the coupling of tube1471 to a pressure-attenuating device 17 mounted thereon, and such that,when push-off member 1521 is positioned in its most distal position,distal end 1527 of tube may be positioned sufficiently distal to distalend 1477 of tube 1471 so as to cause tube 1471 to be physicallydecoupled from a pressure-attenuating device 17 mounted thereon.Although distal end 1527 has been shown herein as having a straight end,it should be understood that distal end 1527 could alternatively beshaped so as to be biased towards the outer diameter of push-off member1521 to minimize the possibility of skiving against device 17 as itapproaches the pushing-off surface of device 17.

Also, it is to be understood that, although inflation tube 1471 has beendescribed herein as being fixed to housing 1401 and push-off member 1521has been described herein as sliding relative both to tube 1471 and tohousing 1401, both tube 1471 and push-off member 1521 could be slidablymounted relative to housing 1401, or tube 1521 could be fixed relativeto housing 1401 and tube 1471 could be slidably mounted relative tohousing 1401. It is also to be understood that, although push-off member1521 has been described herein as being tubular in shape, push-offmember 1521 could be a non-tubular member.

Delivery device 15 may further comprise a trigger 1541 (FIGS. 79-80).Trigger 1541, shown in FIGS. 88(a) and 88(b), may comprise a unitarystructure preferably made of a hard, medical-grade polymer or asimilarly suitable material. Trigger 1541 may be an elongated memberthat may be shaped to include a left side 1543, a right side 1545, aproximal end 1547, a distal end 1549, a top 1551, and a bottom 1553.Trigger 1541 may be partially inserted into barrel portion 1409 ofhousing 1401 through an opening 1542 provided in housing 1401 and may bemounted for pivotal movement using a pair of posts 1555-1 and 1555-2formed on housing halves 1403-1 and 1403-2, respectively, and extendingthrough a transverse opening 1557 in trigger 1541. For reasons to becomeapparent below, left side 1543 may be shaped to include a post 1559extending in the direction of housing half 1403-1.

Proximal end 1547 of trigger 1541 may be shaped to include a tab 1561that may extend proximally at an angle for a short distance. Tab 1561may have a beveled surface 1563 that may permit tab 1561 to slide acrossa rib 1564 extending from housing 1403-2 as trigger 1541 completes itstrigger stroke (i.e., as trigger 1541 pivots clockwise) but that,thereafter, prevents tab 1561 from returning to its original position bysliding back across rib 1564 (i.e., as trigger 1541 pivotscounterclockwise). In this manner, tab 1561 and rib 1564 may effectivelyprevent the return of trigger 1541 to its original position after beingactuated, thereby ensuring that trigger 1541 is squeezed only once. Astab 1561 slides across rib 1564, an audible click may be produced, whichmay be desirable in notifying an operator of device 15 that trigger 1541has completed its clockwise trigger stroke. (As will be discussedfurther below, the squeezing of trigger 1541 is used to release aninflated pressure-attenuating device 17 from delivery device 15.Therefore, the audible click produced by tab 1561 sliding across rib1564 may signal to a user that pressure-attenuating device 17 has beenreleased from delivery device 15.)

Delivery device 15 may further comprise a linkage 1571 (FIGS. 79-80).Linkage 1571, shown in FIGS. 89(a) and 89(b), may comprise a unitarystructure preferably made of a hard, medical-grade polymer or asimilarly suitable material. Linkage 1571 may be an elongated member ofgenerally oval-shape in transverse cross-section comprising a pair oftransverse openings 1573 and 1575. Opening 1573 may be appropriatelydimensioned to receive post 1509 of carriage 1491, and opening 1575 maybe appropriately dimensioned to receive post 1559 of trigger 1541. Inthis manner, by inserting posts 1509 and 1559 into openings 1573 and1575, respectively, linkage 1571 may be used to mechanically coupletrigger 1541 and carriage 1491 such that the squeezing of trigger 1541causes carriage 1491 to be slid from its most proximal position to itsmost distal position. Consequently, because push-off member 1521 may bemechanically coupled to carriage 1491 in the manner described above, thesqueezing of trigger 1541 may cause push-off member 1521 to be movedfrom its most proximal position to its most distal position. The trigger1541 and the linkage 1571 can be part of the release mechanism. In someembodiments, the trigger 1541 can engage one or more of the cartridgeand the push-off member directly with or without some of theintermediate components.

Delivery device 15 may further comprise a safety 1591 (FIGS. 79-80).Safety 1591, shown in FIG. 90, can effectively prevent actuation of thetrigger. Safety 1591 may comprise a unitary structure preferably made ofa medical-grade polymer or a similarly suitable material. Safety 1591may be an elongated member shaped to include a top surface 1593 and abottom surface 1595. A pair of spaced-apart, wedge-shaped cuts 1601 and1603 may be provided in safety 1591, cuts 1601 and 1603 extending frombottom surface 1595 towards, but not completely to, top surface 1593.Cuts 1601 and 1603 may define a proximal segment 1605, an intermediatesegment 1607, and a distal segment 1609, with proximal segment 1605 andintermediate segment 1607 being interconnected by a bridge 1611 and withintermediate segment 1607 and distal segment 1609 being interconnectedby a bridge 1613. Proximal segment 1605 may include a proximal end 1615that may be circular in longitudinal cross-section. End 1615 may beshaped to include a transverse opening 1617 that may be appropriatelydimensioned to receive a pair of posts 1619 and 1621 formed on housinghalves 1403-1 and 1403-2, respectively. Distal segment 1609 may includea distal end 1623 that may be circular in longitudinal cross-section.End 1623 may be appropriately dimensioned to be received within a recess1625 provided in trigger 1541. In this manner, safety 1591 may becoupled at one end to housing 1401 by virtue of the engagement of posts1619 and 1621 with opening 1617, and safety 1591 may be coupled at theopposite end to trigger 1541 by virtue of the engagement of end 1623with recess 1625, with an intermediate length of safety 1591 extendingthrough an opening 1626 in handle portion 1411 of housing 1401.

As can be seen best in FIGS. 91(a) and 91(b), because of theconstruction of safety 1591 and because of the manner in which safety1591 may be coupled to housing 1401 and to trigger 1541, safety 1591 mayassume either a locked state or an unlocked state. When in such a lockedstate, which is shown, for example, in FIG. 91(a), proximal segment 1605is bent downwardly at bridge 1611 relative to intermediate segment 1607,and distal segment 1609 is bent downwardly at bridge 1613 relative tointermediate segment 1607. In this state, compressive pressure appliedto safety 1591 at ends 1615 and 1623, such as by applying a squeezingforce to trigger 1541, cannot readily cause ends 1615 and 1623 to bedrawn appreciably closer to one another; thus, trigger 1541 iseffectively prevented from being actuated. By contrast, as seen in FIG.91(b), when proximal segment 1605 is bent upwardly at bridge 1611 andwhen distal segment 1609 is bent upwardly at bridge 1613, compressivepressure applied to safety 1591 at ends 1615 and 1623, such as byapplying a squeezing force to trigger 1541, causes ends 1615 and 1623 tobe drawn considerably closer to one another as safety 1591 bends atbridge 1611, thereby enabling trigger 1541 to be actuated. Moreover,safety 1591 may be transformed from its locked state to its unlockedstate simply by applying sufficient force to the top surface ofintermediate segment 1607 to cause proximal segment 1605 and distalsegment 1609 to pivot about bridges 1611 and 1613, respectively. Suchforce may be provided, for example, using the index finger or thumb ofthe hand used to grip trigger 1541. The safety can be an ambidextroussafety.

Delivery device 15 may further comprise a window catheter 1641 (FIGS.79-80). Catheter 1641, which is also shown separately in FIGS. 92(a)through 92(c), may comprise a unitary structure preferably made of amedical-grade polymer or a similarly suitable material having columnarstrength with some angular flexibility. Though illustrated as a separatepiece from the housing 1401, it will be understood that the windowcatheter 1641 can be part of housing and may be made integral with oneor more of the other housing components or parts. Catheter 1641 maycomprise a side wall 1643 defining an open proximal end 1645, a closeddistal end 1647, a channel 1649 extending longitudinally from openproximal end 1645 up to closed distal end 1647, and a window 1651 spaceda short distance from distal end 1647 and providing top access tochannel 1649 through side wall 1643. The closed distal end 1647 can bean atraumatic end or shape, such as a rounded or hemispherical end.Proximal end 1645 of catheter 1641 may have an enlarged profile relativeto the remainder of catheter 1641, which can be generally circular intransverse cross-section for most of its length. The enlarged crosssection can be may be generally rectangular in transverse cross-section.This enlarged proximal end 1645 of catheter 1641 may be fixedly mountedwithin barrel portion 1409 of housing 1401 and may be disposed on asupport 1653 formed on half 1403-2, with the remainder of catheter 1641extending distally through opening 1419 in housing 1401 and continuingdistally for several inches. (A complementary support 1655 on half1403-1 may be provided to furnish additional support to end 1645.)Inflation tube 1471 and push-off member 1521 may be coaxially receivedwithin channel 1649 (with inflation tube 1471 also being coaxiallyreceived within push-off member 1521), with channel 1649 having asufficiently large diameter to permit push-off member 1521 to slidefreely therewithin.

As will be discussed further below, pressure-attenuating device 17 maybe disposed at least partially within channel 1649 during the insertionof device 15 into a desired anatomical structure of a patient and duringinflation of pressure-attenuating device 17. Pressure-attenuating device17 may be released from channel 1649 through window 1651 when deploymentof device 17 is desired. Accordingly, window 1651 may be appropriatelyshaped to promote retention of pressure-attenuating device 17 withinchannel 1649 during the aforementioned insertion and inflation steps andto promote release of pressure-attenuating device 17 from channel 1649through window 1651 when deployment is desired. To this end, in thepresent embodiment, window 1651 may be shaped to include a proximalportion 1652-1, a distal portion 1652-2, and an intermediate portion1652-3. Proximal portion 1652-1 and distal portion 1652-2 may besubstantially similar to one another and may be comparatively narrowerand comparatively shallower than intermediate portion 1652-3, withintermediate portion 1652-3 transitioning from the width and depth ofproximal portion 1652-1 and distal portion 1652-2 to a maximum width anddepth between proximal portion 1652-1 and distal portion 1652-2. Each ofwindow 1651 and catheter 1641 may be appropriately dimensioned in lengthso that the distal end 1477 of inflation tube 1471 may be approximatelyaligned with the transition in window 1651 from proximal portion 1652-1to intermediate portion 1652-3. Moreover, each of window 1651 andcatheter 1641 may be appropriately dimensioned in length so that, whenpush-off member 1521 is in its most distal position, the distal end 1527of push-off member 1521 may be approximately aligned with the midpointof intermediate portion 1652-3 of window 1651.

The cross section of catheter 1641 at the proximal portion of the window1652-1 has an opening between 1 and 270 degrees, more preferably between20 and 180 degrees, more preferably between 50 and 120 degrees, and morepreferably approximately 95 degrees. The cross section of catheter 1641at the middle portion of the window 1652-2 has an opening between 1 and270 degrees, more preferably between 20 and 180 degrees, more preferablybetween 50 and 180 degrees, and more preferably approximately 151degrees. The cross section of catheter 1641 at the distal portion of thewindow 1652-3 has an opening between 1 and 270 degrees, more preferablybetween 20 and 180 degrees, more preferably between 50 and 120 degrees,and more preferably approximately 102 degrees.

FIG. 92(d) illustrates an embodiment in which catheter 1641 includes afeature 1647-1 intended to manipulate the holding force and radialexpansion force of the delivery system on an attenuator via spring-likecompliance. A feature, such as 1647-1, may provide an advantageous forcebalance between retention force during the aforementioned insertion, andresistance to radial expansion during inflation steps to promote releaseof pressure-attenuating device 17 from channel 1649 through window 1652when deployment is desired. In some embodiments, the distal end 1647 ofcatheter 1641 comprises a slit or cut 1647-1. The slit or cut 1647-1 mayimprove compliance of catheter 1641 without altering the materialgeometry of the catheter 1641, or geometry of window 1652. For example,small cuts or slits 1647-1 may improve the inflation and/or deploymentof pressure-attenuating device 17 by reducing a restraining and radialexpansion force of the catheter 1641 on the attenuator. FIG. 92(e) showsa top view of a catheter 1641 having a window 1652 and a cut or slit1647-1 at the distal end 1647 of catheter 1641.

In some embodiments, slit 1647-1 has a length within a range of fromabout 0.010 inches (in.) to about 1.000 in., while in other embodimentsthis length is from about 0.015 in. to about 0.500 in. In someembodiments, the slit 1647-1 may have a length of about 0.25 in., about0.20 in., or about 0.15 in. Slit 1647-1 may also comprise other lengths.In some embodiments, slit 1647-1 comprises a width less than about 0.200in., such as less than about 0.125 in., and in some cases less thanabout 0.025 in. Slit 1647-1 may also comprise other widths.

The distal end 1647 of catheter 1641 may comprise an opening or hole1647-2. For example, FIG. 92(f) shows a catheter 1641 having both a cutor slit 1647-1 and an opening 1647-2 at the distal end 1647 of thecatheter 1641. In some embodiments, the opening 1647-2 may enable areduced restraining force, reduced radial expansion force, and/orincreased flexibility during inflation of pressure-attenuating device 17stored within catheter 1641. In some embodiments, the distal end 1647comprises a chamfer, for example suitable for facilitating catheter 1641placement. The chamfer provides a gradual widening in the width of thedistal end 1647 to facilitate atraumatic advancement. FIG. 92(g) shows atop view of a catheter 1641 having both a slit 1647-1 and an opening1647-2 at the distal end 1647 of catheter 1641. By providing the opening1647-2, in the event of an improperly inflated or incomplete release ofa device, the device can be manipulated into opening 1647-2 during thedelivery devices retraction into or during the advancement of an overlying sheath, cover, or member to promote the tensile release of thedevice in the coaxial direction of catheter 1641.

In some embodiments, the opening 1647-2 comprises a circular orsubstantially circular shape. For example, a circular opening 1647-2 cancomprise a diameter within the range of from about 0.010 in. to about0.250 in., such as from about 0.025 in. to about 0.200 in., andincluding from about 0.050 in. to about 0.150 in. Opening 1647-2 maycomprise other shapes and/or sizes.

Referring to FIG. 92(h), in some embodiments, catheter 1641 has a slit1647-1 and a circular or substantially circular opening 1647-2 thatcomprises a substantially continuous slot 1647-3. FIG. 92(i) shows a topview of a catheter 1641 having both a slit 1647-1 and a circular orsubstantially circular opening 1647-2 at the distal end 1647 of catheter1641, where the slit 1647-1 and the opening 1647-2 comprise asubstantially continuous slot 1647-3. This arrangement may enable areduced restraining force, reduced radial expansion force, and/orincreased flexibility during inflation of pressure-attenuating device 17stored within catheter 1641. In addition, this arrangement provides acontinuously open area connecting the opening 1652 and the opening1647-2 so that in the event of an improperly inflated or incompleterelease of a device, the device can be easily manipulated into opening1647-2 during the delivery devices retraction into or during theadvancement of an over lying sheath, cover, or member to promote thetensile release of the device in the coaxial direction of catheter 1641.

Referring to FIG. 92(j), a distance D between the distal end 1647 and adistal portion 1652-2 of window 1652 may be varied. A position of thewindow 1652 of the catheter 1641, for example a position relative to thedistal end 1647 of the catheter 1641, may facilitate proper deploymentof pressure-attenuating device 17. In some embodiments, the catheter1641 having a window 1652 positioned a distance D from the distal end1647 of catheter 1641 facilitates storage of pressure-attenuating device17, for example during shipping and handling, and enables properdeployment of pressure-attenuating device 17 from the catheter 1641 intoa patient. FIG. 92(j) shows a cross-sectional view of catheter 1641having no opening 1647-2, the catheter 1641 having a distance D betweena distal portion 1652-2 of window 1652 and the distal end 1647. In someembodiments, the distance D comprises a value less than about 0.500 in.,such as less than about 0.250 in., and in some cases less than about0.150 in.

FIG. 92(k) shows a cross-sectional view of catheter 1641 comprising anopening 1647-2, the catheter 1641 having a distance D1 between a distalportion 1652-2 of window 1652 and the distal end 1647. This variationmay have the same dimensions as D set forth above, but provides theadvantage that if an attenuator is fully advanced within the catheter1641 there will be no contact between the device 17 disposed within thecatheter 1641 and the area of the opening 1647-2. This may reducerestraining force in that region. Additionally, compared to theembodiment of FIG. 92(j), a smaller arcuate zone of contact is providedbetween the central longitudinal axis of the catheter 1641 and theopening 1652. The angle between the uppermost edge of the circumferenceof the opening 1647-2 and the distal-most edge of the opening 1652 maybe less than 45 degrees, e.g., less than about 30 degrees, and in somecases 15 degrees or less. This reduces the amount of overhang betweenthe inner surface of the distal end and the opening 1652 to reduce therestraining force at the distal end.

FIG. 92(l) shows a cross-sectional view of catheter 1641 having noopening 1647-2, the catheter 1641 having a reduced distance D2 between adistal portion 1652-2 of window 1652 and the distal end 1647. In thisembodiment, there is very little and in some modified embodiments thereis no overhang between the distal inner surface of the catheter 1641 andthe opening 1652 because the opening extends to the end of the catheter1641.

Delivery device 15 may further comprise a sealing ring 1661. Ring 1661,which is also shown separately in FIG. 93, may comprise a unitarystructure preferably made of a medical-grade silicone or a similarlysuitable material. Ring 1661 may be coaxially mounted over push-offmember 1521 and may be fixedly mounted within barrel portion 1409 ofhousing 1401, with ring 1661 being sandwiched between proximal end 1645of catheter 1641 and complementary supports 1663 and 1665 formed onhousing halves 1403-1 and 1403-2, respectively. Ring 1661 may beappropriately dimensioned to provide a fluid-tight seal with proximalend 1645 of catheter 1641 so that any fluids entering catheter 1641through window 1651 do not leak from proximal end 1645.

One or more syringes can be connected to or be part of the deliverydevice 15 (FIGS. 79-80). First syringe 1671, shown in FIG. 94, maycomprise a tubular body 1675 containing a desired quantity of a firstinflation medium 1677 for use in inflating pressure-attenuating device17, a piston 1679 slidably mounted in body 1675, and a male luerconnector 1681. Body 1675 may be appropriately sized for insertion intoopening 1417, and connector 1681 may be appropriately sized for matingwith proximal end 1459 of valve 1443. In the present embodiment,inflation medium 1677 may be a fluid and more specifically may be one ormore high vapor pressure media that may serve as a pressure regulator tohelp keep device 17 inflated. The one or more high vapor pressure mediamay be, for example, one or more liquid perfluorocarbons (PFCs),preferably one or more liquid PFCs having a vapor pressure greater than50 Pa. (The one or more liquid perfluorocarbons may sometimesalternatively be referred to herein as “AIRLOC®.”) The one or moreliquid PFCs may comprise a perfluorinated heptane, a perfluorinatedoctane, or one or more combinations thereof. Preferably, the one or moreliquid PFCs are a mixture of perfluoroheptane and perfluorooctane. Sucha mixture can range from about 0.05 mole fraction of perfluoroheptaneand about 0.95 mole fraction of perfluorooctane to about 0.95 molefraction of perfluoroheptane and about 0.05 mole fraction ofperfluorooctane, more preferably can range from about 0.2730 molefraction of perfluoroheptane and about 0.7270 mole fraction ofperfluorooctane to about 0.7270 mole fraction of perfluoroheptane andabout 0.2730 mole fraction of perfluorooctane, even more preferably canrange from about 0.3640 mole fraction of perfluoroheptane and about0.6360 mole fraction of perfluorooctane to about 0.5450 mole fraction ofperfluoroheptane and about 0.4550 mole fraction of perfluorooctane. Inone particular embodiment, the mixture includes about 0.4548 molefraction of perfluoroheptane and about 0.5452 mole fraction ofperfluorooctane. For example, about 25 ml of this perfluorocarbonmixture can be manufactured by mixing about 18.336 grams ofperfluoroheptane with about 24.8099 grams of perfluorooctane.

Delivery device 15 may further comprise a second syringe 1691. Secondsyringe 1691, which is also shown separately in FIG. 95, may comprise atubular body 1693 containing a desired quantity of a second inflationmedium 1695 for use in inflating pressure-attenuating device 17, apiston 1697 slidably mounted in body 1693, and a male luer connector1699. Body 1693 may be appropriately sized for insertion into opening1413, and connector 1699 may be appropriately sized for mating withproximal end 1449 of valve 1441. In the present embodiment, medium 1695may be a fluid and more specifically may be a gas, such as air. Where,for example, one or more PFCs are used as inflation medium 1677, and airis used as inflation medium 1695, the relative volumes of the one ormore PFCs to air may range, for example, from about 1 (PFC(s)):1000(air)to about 1(PFC(s)):1(air). In addition, where, for example,pressure-attenuating device 17 is appropriately dimensioned for use inthe human bladder, syringe 1691 may contain approximately 25-30 cc ofair.

Preferably, the respective quantities of first medium 1677 disposedwithin body 1675 of syringe 1671 and second medium 1695 disposed withinbody 1693 of syringe 1691 are sufficient to inflate pressure-attenuatingdevice 17 to a desired extent, taking into account the fact that thetotal volume of one or both fluid media may not be transferred entirelyfrom syringes 1671 and 1691 to device 17, but rather, that a portion ofthe volume of one or both inflation media may be left behind in thefluid passageways extending from check valves 1443 and 1441 to distalend 1477 of inflation tube 1471. For example, the amount of first medium1677 present within device 17 can range from about 0.01-1 liter,preferably from about 0.1 to 30 ml, more preferably from about 0.2 to 10ml. Therefore, to determine the amount of first medium 1677 that shouldbe loaded into syringe 1671, the amount of first medium 1677 thatremains in the delivery system may be added to the minimum target amountof first medium 1677 to be delivered to device 17. For example, if thetarget amount of first medium 1677 is about 0.45 ml, and the potentialretention of first medium 1677 remaining within the delivery system is0.25 ml, the amount of first medium 1677 initially loaded into syringe1671 may be about 0.7 ml. It should be apparent to one of ordinary skillin the art that more accurate and reproducible placement of first medium1677 into device 17 may occur by reducing the amount of fluid volumeretained in the delivery system. This can be achieved by firstdispensing medium 1677 into device 17 and then by dispensing secondmedium 1695 and/or by reduction of the dimensions of the variouscomponents of the delivery device 15.

It is to be understood that, although media 1677 and 1695 have beendescribed herein as being essentially inert or non-reactive with oneanother, media 1677 and 1695 may be reactive with one another to form,for example, a third medium which, itself, may be used to inflate device17. It is also to be understood that, although media 1677 and 1695 havebeen described herein as being used to inflate device 17, medium 1677could be used to inflate device 17 and medium 1695 could be used as asealant to seal the valve or port through which medium 1677 isintroduced into device 17 to prevent medium 1677 from leaking fromdevice 17. In addition, it may be desirable to inject other substancesinto the balloon, such as a medication.

Referring now to FIGS. 96(a) and 96(b), there are shown side views of analternate embodiment of a delivery device to delivery device 15, thealternate embodiment being represented generally by reference numeral1701.

Delivery device 1701 may be similar in most respects to delivery device15. One difference between the two delivery devices may be that, whereasdevice 15 may include window catheter 1641, delivery device 1701 mayinclude a window catheter 1702. Window catheter 1702 may be similar inmost respects to window catheter 1641, the principal difference betweenthe two window catheters being that, whereas window catheter 1641 mayinclude window 1651, window catheter 1702 may include a window 1703.Window 1703 may include a proximal portion 1704-1, a distal portion1704-2, and an intermediate portion 1704-3. Proximal portion 1704-1 andintermediate portion 1704-3 may be similar to proximal portion 1652-1and intermediate portion 1652-3, respectively, of window 1651. However,distal portion 1704-2 of window 1703 may differ from distal portion1652-1 of window 1651 in that distal portion 1704-2 may extend all theway to distal end 1705 of window catheter 1702 and may be deeper thanproximal portion 1704-1 and/or intermediate portion 1704-3 for at leastsome of its length. It is believed that the increased size of window1703, as compared to the size of window 1651, may facilitate the passageand release of pressure-attenuating device 17 from the delivery device.

Another difference between the two delivery devices is that deliverydevice 1701 may further include a cover 1707 slidably mounted overcatheter 1641. Cover 1707, which is also shown separately in FIG. 97,may comprise a generally tubular member 1708 having a proximal end1708-1 and a distal end 1708-2. Cover 1707 may also comprise a hub 1710secured to the proximal end 1708-1 of member 1708. As can be seen inFIG. 96(a), when cover 1707 is in its distal position, distal end 1708-2may be positioned so that cover 1707 covers window 1703 of catheter1702. This may be useful in retaining pressure-attenuating device 17within catheter 1641. On the other hand, as can be seen in FIG. 96(b),when cover 1707 is in its proximal position, distal end 1708-2 may bepositioned so that cover 1707 does not cover window 1703 of catheter1702. In use, cover 1707 may initially be positioned as in FIG. 96(a),and that, as device 1701 is inserted through access device 13, handle 71may engage hub 1710 and may cause cover 1707 to be slid proximallyrelative to catheter 1702 until it assumes the position shown in FIG.96(b), thereby “opening” window 1703 to allow device 17 to passtherethrough in the manner described above. Distal end 1708-2 may have atapered geometry to aid in its introduction through an orifice, such asthat of access device 13 or some anatomical orifice. This tapered endcan also decrease the likelihood that the cover will be prematurelyretracted through contact with such an orifice. Also, it is to beunderstood that, although not shown, cover 1707 and/or catheter 1702 maybe provided with some mechanism, such as a catch or one or moreengagement surfaces, that may serve to impede, to a certain extent,axial movement of cover 1707 relative to catheter 1702 so thatinadvertent proximal and/or distal movement of cover 1707 relative tocatheter 1702 may be avoided.

Referring to FIG. 98(a), in some embodiments, a cover 1707, which mayfor example be suitable for retaining pressure-attenuating device 17within any of the catheters described herein, e.g., the catheter 1702.The cover 1707 can be removed, e.g., retracted distally. The cover 1707may comprise a proximal end 1708-1 and a distal end 1708-2. The cover1707 may comprise a handle 1708-3 on the distal end 1708-2. In someembodiments, the proximal end 1708-1 is sized to slide over and cover,at least in part, the window 1703 of catheter 1702. For example, thecover 1707 may reduce displacement of the pressure-attenuating device 17prior to removal of the cover 1707. In some embodiments, the cover 1707comprises a plastic material (e.g., polytetrafluoroethylene (PTFE),polyethylene (PE), synthetic polymers such as nylon). In someembodiments, the cover 1707 comprises polyethylene terephthalate (PET)heat shrink. In some embodiments, cover 1707 comprises a metallicmaterial (e.g., stainless steel, titanium, a nickel-titanium alloy(Nitinol), aluminum).

The cover 1707 may facilitate the un-inflated pressure-attenuatingdevice 17 to “take a set” over time while stored in catheter 1702 havingwindow 1703. For example, at time zero when the pressure-attenuatingdevice 17 is folded and packed into the catheter 1702, thepressure-attenuating device 17 may be unstable and the cover 1707 and/orcatheter 1702 may provide physical restraint upon thepressure-attenuating device 17. In some embodiments, the physicalrestraint enables the pressure-attenuating device 17 to take a set byfacilitating retention of the device 17 within catheter 1702 havingwindow 1703. For example, a pressure-attenuating device 17 may take aset by becoming more rigidly stored within catheter 1702, such thatdevice 17 may be more stably retained in catheter 1703, including acatheter 1703 having features to increase catheter 1703 compliance(features as described herein). In some embodiments, a time tofacilitate the pressure-attenuating device 17 to take a set can have avalue within a range of from about 1 minute to about 1 month, includingfrom about 1 hour to about 2 weeks, including from about 1 hour to about1 week. In some embodiments, the catheter 1702 having a window 1703 andcontaining a pressure-attenuating device 17, and a cover 1707 coveringat least a portion of window 1703 of catheter 1702, may be subjectedelevated temperature during the manufacturing process to facilitate thepressure-attenuating device 17 to take set.

FIG. 98(b) shows a profile view of a cover 1707 having a handle 1708-3at the distal end 1708-2 and a proximal end 1708-1 suitable forcovering, at least in part, the window 1703 of catheter 1702. FIG. 98(c)shows a cross-sectional view of a cover 1707 having a handle at thedistal end 1708-2 and a proximal end 1708-1 suitable for covering, atleast in part, the window 1703 of catheter 1702.

The cover 1707 may be removed, for example, during manufacturing,immediately prior to packaging and sterilization, or immediately priorto the use of the delivery system. The cover 1707 can be removedmanually, or can be attached to the packaging so that removal of thesystem from the packaging also removes the cover. Referring to FIG.98(d), a tab 1709 may be attached to the cover 1707 distal end 1708-2,including for example the handle portion. In some embodiments, the tab1709 facilitates removal of the cover 1707. For example, the cover 1707having the tab 1709 may be placed over at least a portion of window 1703of catheter 1702, catheter 1702 containing a pressure-attenuating device17. In some embodiments, as the delivery system is removed from thepackaging tube, the tab 1709 contacts the packaging tube and isrestrained, and the catheter 1702 slides out of the cover 1707 andpackaging tube. For example, the packaging tube may comprise theprotective sleeve 1759 as shown in FIG. 106.

Implant

An implantable device having a compressible element can be placed withina body, such as the bladder. The compressible element can act as apressure attenuator to attenuate transient pressure events. Gases, suchas atmospheric air, carbon dioxide, nitrogen, and certainperfluorocarbons (PFC), may be used to inflate the implant and can actas a low or variable rate spring in series with the native fluidiccircuit of the urinary tract. The implant can take many forms includinga sphere, some examples of which will be outlined below.

In some embodiments, the implant can include an outer surface thatdefines a container within the outer surface. The implant may alsoinclude a valve that can allow for the addition or removal of substancesfrom the container.

Additional embodiments of an implantable device are described in U.S.Pat. No. 6,682,473, incorporated by reference herein. See for example,FIGS. 5, 5A, 7A-C, 8A-E, 13-25, and 27-31, and the accompanyingdiscussion, including at columns 9-12, 13-14, 17-20, and 21-24. See alsothe similar disclosure from U.S. Pat. No. 6,976,950, incorporated byreference herein, as well as, FIGS. 32A-33C, 36-38, 47A-C, 49 and theaccompanying discussion, including at columns 15-18, 30-35, and 39-40.

U.S. Patent Application Publication No. 2010/0222802, incorporated byreference herein discloses still additional embodiments of implantabledevices. See for example, FIGS. 5-5N, 8A-8B, 10A, 11C, 23A-23H, 34A-35D,37A-37B, 38A-51C, and the accompanying discussion, including paragraphs[0127]-[0152], [0167]-[0168], [0174], [0177], [0233]-[0242],[0354]-[0438], and [0466]-[0475].

Referring now to FIG. 99(a) through 100, implant or pressure-attenuatingdevice 17 may comprise an inflatable cell 1711 and a valve 1713. Thevalve 1713 can serve to regulate the flow of fluid into and out of cell1711. Cell 1711 may be made of an elastomeric material. When inflated,cell 1711 may comprise a generally spherical bulb portion 1714 and aninverted tubular tail portion 1717 extending into bulb portion 1714,tail portion 1717 terminating in an opening 1719 (FIG. 100). An area ofincreased wall thickness or retaining feature 1715 may be disposed onbulb portion 1714 opposite to tail portion 1717.

The retaining feature 1715 can be a portion of the balloon that is usedto retain the balloon into the window of the delivery system. Theretaining feature 1715 can be an area of the cell 1711 that is the sameor higher wall thickness than adjacent areas of the cell 1711, or amember that is more rigid than the cell 1711, which can be integral toor adhered to the cell 1711, as an example. In the present embodiment,cell 1711 may be made of a sufficiently transparent material to permitthe contents housed by cell 1711 to be seen.

Cell 1711 may be seamless and may be substantially arcuate, with theonly exception being tail portion 1717, which is inverted and to whichvalve 1713 can be welded or otherwise attached. To minimize thepotential for encrustation, to maximize patient tolerability, or forother reasons, it is preferable that over 95% of the external surfacearea of cell 1711 be continuously arcuate and that less than 5% of thesurface area of cell 1711 not be arcuate. More preferably, over 97% ofthe external surface area of cell 1711 is continuously arcuate and lessthan 3% of the external surface area is not arcuate. Even morepreferably, over 99% of the external surface area of cell 1711 iscontinuously arcuate and less than 1% of the surface area is notarcuate.

For example, one embodiment of cell 1711 has an overall surface area of4,586 sq. mm. The external surface area of the continuously arcuateportion of cell 1711 is 4,575 sq. mm. The ratio of continuously arcuatesurface area to non-arcuate surface area for this embodiment is 401:1.This ratio is preferably from about 100:1 to 1500:1 and more preferablyfrom about 400:1 to 600:1. The diameter of tail portion 1717 in theembodiment above is 0.15 inch, and the diameter of bulb portion 1714 is1.58 inches. The ratio of the diameter of bulb portion 1714 to thediameter of tail portion 1717 is 10.53:1. This ratio is preferablybetween about 6:1 and 20:1 and more preferably greater than about 8:1.Without limitation to any particularly theory or embodiment, it isbelieved that such a ratio may serve to keep tail portion 1717 invertedwithin bulb portion 1714.

Valve 1713, which is also shown in FIG. 101, may be formed from a pairof matching, appropriately shaped, flat sheets of elastomeric material.The pair of matching flat sheets may be heat-sealed to one another alongtheir respective sides to form a pair of seams 1720-1 and 1720-2 and mayalso be molded so as to define a proximal section 1721, an intermediatesection 1723, and a distal section 1725. Proximal section 1721 may begenerally flat or generally frusto-conical in shape and may includeouter surfaces 1721-1 and 1721-2 that may be fixedly mounted withinopening 1719 of cell 1711 (FIG. 100) by a flat weld (where proximalsection 1721 is flat) or by a circumferential weld (where proximalsection 1721 is frusto-conical.) Proximal section 1721 may include anend surface 1722, which may be a surface or mating surface, intended tointerface the distal end 1527 of push-off member 1521, thereby allowingpush-off member 1521 to push device 17 off distal end 1477 of inflationtube 1471. In one embodiment, this surface 1722 is a 90 degree flatsurface. Other surfaces, such as a concave or convex surface thatinteracts with the distal end of push-off member 1521. The shape of thedistal end of the pushoff member 1521 may be flat, concave, convex, or ashape that permits interaction with the end surface 1722. Intermediatesection 1723 may be generally cylindrical and may be reduced in innerdiameter and in outer diameter as compared to proximal section 1721.Moreover, intermediate section 1723 may be reduced in inner diameter ascompared to the outer diameter of inflation tube 1471 and may include aninner side surface 1724 that may be used to make a stretch interferencefit with inflation tube 1471 so as to seal against inflation tube 1471or to prop open valve 1713, which will close upon release, therebyenabling cell 1711 to be inflated under high pressure with minimalleaking. For example, where the outer diameter of inflation tube 1471may be in the range of about 0.001-5.00 inch, preferably about0.005-0.50 inch, more preferably about 0.010-0.125 inch, the innerdiameter of intermediate section 1723 may be correspondingly smaller,for example, in the range of about 0.0005-4.900 inch, preferably about0.001-0.49 inch, more preferably about 0.005-0.120 inch. Moreover, thethickness of intermediate section 1723 may be in the range of about0.0001-2.00 inch, preferably about 0.001-0.24 inch, more preferablyabout 0.005-0.050 inch. In certain applications, the nominal pressureexerted on the self sealing valve 1725 is relatively low, below 3 psi.Therefore the surface area of the contact area of the two surfaces mustbe sufficient to resist flow during use. This is accomplished with astructure 1725 that has a width typically less than 1′, more preferablyless than 0.5 inches, and more preferably less than 0.25 inches. Tomaintain valve function, the length of the structure 1725 is greaterthan the width of structure 1725, more preferably the length is greaterthan 1.5 times the width of the structure 1725, and more preferablygreater than two times the width of the structure 1725. Distal section1725 may be a generally elongated, flattened structure that isself-sealing (i.e., biased, independently of its environment, towards aclosed state) and that has a distal end 1727 through which fluidinputted to valve 1713 in the manner discussed below may exit valve 1713to occupy the space defined by cell 1711. Preferably, distal section1725 is made sufficiently long to minimize the escape of fluid fromwithin cell 1711 through valve 1713.

Referring now to FIG. 102, there is shown a flowchart, schematicallydepicting one possible method 1731 for making device 17. Method 1731 maybegin with a step 1731-1 of providing a tubular member, which may be,for example, an extruded tube 1733 of elastomeric material having a pairof open ends 1734-1 and 1734-2 (see FIG. 103(a)). Method 1731 maycontinue with a step 1731-2 of closing off end 1734-2 to form a tube1735 having a closed end 1735-1 (see FIG. 103(b)). Method 1731 may thencontinue with a step 1731-3 of blowing up or expanding tube 1735 to forma generally spherical portion 1736 and a generally cylindrical tailportion 1737 (see FIG. 103(c)). (Step 1731-3 may further include pullingon the closed end 1735-1 during said expansion of tube 1735.) Method1731 may then continue with a step 1731-4 of inserting valve 1713 intotail portion 1737 and joining, such as by either a circumferential weldor a flat weld, proximal section 1721 to tail portion 1737 (see FIG.103(e)). Method 1731 may then conclude with a step 1731-5 of invertingthe combination of valve 1713 and tail portion 1737 into generallyspherical portion 1736, thereby forming device 17. In some embodiments,to prevent the valve 1713 and tail portion 1737 from reversing thisinverting step 1731-5 during use, the valve and tail portion may beanchored to the balloon wall in any method known in the art includingbut not limited to use of an adhesive or welding the distal end of thevalve to the balloon wall, for example. A preferred embodiment is tofabricate the balloon to provide increase resistance to the reversal ofinverting step 1731-5 with the following features: 1) An increase inwall thickness or stiffness on the balloon near the area of the balloonwhere the tail protrudes. For example, a circumferential increase inballoon thickness 1736-1 that measures more than two times the diameterof the tail, and more preferably more than 1.5 times the diameter of thetail and more preferably more than one times the diameter of the tail,and this circumferential wall thickness is less than 0.075 inches andmore preferably less than 0.050 inches and more preferably less than0.025 inches, and/or 2) a wall thickness of the tail 1737 that is atleast one times the wall thickness of the balloon 1736, more preferablyat least 1.5 times the wall thickness of the balloon 1736, morepreferably at least two times the wall thickness of the balloon 1736,more preferably at least three times the wall thickness of the balloon1763, and/or 3) a balloon with a measured angle between the wall of theballoon near the tail opening and the tail 1736-2 of at least 45degrees, more preferable greater than 70 degrees, more preferablegreater than 80 degrees, and more preferable approaching 90 degrees,and/or 4) a measured radius where the tail 1737 interfaces with balloon1736 of less than 0.5 inches, more preferably less than 0.1 inches, morepreferably less than 0.075 inches and more preferably less than 0.035and preferably 0.015 inches. Preferably, device 17 is dimensioned sothat spherical portion 1736, when expanded, has a diameter that isapproximately 6-20 times the diameter of the entry port defined by theinterface of spherical portion 1736 and inverted tail portion 1737. Inone embodiment, the shape, thickness and material of closed end 1735-1forms the integral retaining member 1715 in the wall of the balloon.

Cell 1711 may alternatively be made using a dip process that is commonin the industry. For example, Brash et al., “Development of blockcopolyether-urethane intra-aortic balloons and other medical devices,”Journal of Biomedical Research, 7(4):313-34 (1973), which isincorporated herein by reference, describe a manufacturing process thatcan be used to manufacture cell 1711. A mandrel is formed fromexpendable wax, and then dipped using commonly known balloon dippingmethods to form a balloon. Upon cure of the balloon material, the wax ismelted and removed, resulting in the desired balloon.

One advantageous feature of device 17 is that it may be devoid of seamson its exterior surface. The absence of such seams may be desirablesince such seams may rub up against and cause irritation with thebladder or other anatomical structure in which device 17 is positioned.In addition, such seams may become encrusted, over time, with biologicalsediment from the anatomical structure in which device 17 is positioned,which encrustation may exacerbate such irritation or may otherwise beregarded as unhygienic or undesirable.

Delivery and Expansion of Implant

As noted above, device 17 may be delivered to an anatomical structure ina compacted or deflated state and, after being delivered to theanatomical structure, may be inflated and deployed. Preferably, thedelivery of device 17 to the anatomical structure in a deflated state isaccomplished by positioning device 17 in its deflated state withinwindow catheter 1641, with distal end 1477 of inflation tube 1471 sealedagainst intermediate section 1723 of valve 1713 in the manner discussedabove. As seen in FIG. 104, cell 1711 may be folded within catheter 1641in a manner complementary to the shape of window 1651 so as to maximizethe likelihood that device 17 may be retained within catheter 1641 bywindow 1651 prior to being inflated and may be released through window1651 once inflated.

Referring now to FIG. 105, device 17 is shown in a deflated, flattenedstate with internal retention member 1715 on the lower layer of theballoon prior to being folded. A plurality of imaginary fold lines1741-1, 1741-2, and 1741-3 are shown on cell 1711 to depict where cell1711 may be folded. According to one embodiment of the invention, cell1711 may first be folded about line 1741-1, then about line 1741-2, andthen about line 1741-3. Alternatively, cell 1711 may be folded aboutline 1741-2, then about line 1741-1, and then about line 1741-3. Whendevice 17 is inflated, cell 1711 may unfold in an order opposite to theorder in which it had previously been folded. In an alternateembodiment, the balloon includes an integral retention member 1715,which is on top of the balloon when folded along line 1741-1 describedabove. The integral retention member may be circular, rectangular, ovalor any shape so long as it is sufficiently wide to extend beyond theopening in the window, more preferably greater than 1.5 times theopening in the window, more preferably two times the opening in thewindow. This dimension permits the retention member to be tucked underthe catheter on one or more sides of the window when the folded balloonis secured in the catheter.

It is to be understood that, although device 17 has been describedherein as being inflatable, device 17 could be expandable in ways otherthan by inflation. For example, device 17 could be self-expandable, forinstance, by virtue of being made of a shape-memory material.

Referring now to FIG. 106, there is shown a top view of one embodimentof a sterilizable kit comprising certain components of system 11, thesterilizable kit being represented generally by reference numeral 1751.

Kit 1751 may comprise a sheet of support material 1753, which may be asheet of cardboard or a similarly suitable support material. Kit 1751may further comprise a sealed pouch 1755 surrounding support material1753, pouch 1755 defining a sealed cavity 1757. Pouch 1755 may be madeof a transparent material, such as one or more transparent polymersheets. Kit 1751 may further comprise the components of delivery device15, excluding syringe 1671 (which syringe 1671 may be separatelysterilized, for example, through heat-sterilization), the components ofdelivery device 15 nearly being fully assembled, except that syringe1671 is not present and that syringe 1691 is not attached to theremaining components of delivery device 15. Syringe 1691 may be disposedwithin cavity 1757 and may be mounted on support material 1753, and theremainder of delivery device 15 may be disposed within cavity 1757 andmay be mounted on support material 1753 at a distance from syringe 1691.Syringe 1691 may be opened to drawn in a volume of air corresponding tothe volume of air one wishes to dispense therefrom into device 17.Although not visible in FIG. 106, kit 1751 may further comprisepressure-attenuating device 17, which may be loaded within windowcatheter 1641 of delivery device 15 and may be coupled to inflation tube1741 in the manner described above. Kit 1751 may further comprise aremovable protective sleeve 1759, which may be inserted over catheter1641 to ensure retention of device 17 within catheter 1641 duringshipping and/or storage. (Sleeve 1759 is removed from catheter 1641prior to use; alternatively, sleeve 1759 may be replaced with cover1703, which may be retained for use in the manner described above.) Allof the components of kit 1751 are made of a material that may besterilizable by a suitable sterilization technique, such as gammaradiation.

An advantageous feature of kit 1751 is that the air contained withinsyringe 1691 may become sterilized during the sterilization procedureapplied to kit 1751. In this manner, one may minimize the introductionof air into device 17 that may contain undesirable microorganisms. Forsimilar reasons, microbial filters may alternatively or additionally beappropriately positioned within fluid connector 1423 and/or check valves1441 and 1443.

Referring now to FIG. 107, there is shown a flowchart, schematicallydepicting one possible method 1771 of implanting pressure-attenuatingdevice 17 in an anatomical structure of a patient, such as a bladder.Method 1771 may begin with a step 1771-1 of installing an access devicein a patient in any of the manners discussed above. Where, for example,access device 13 is used to provide transurethral access to the bladder,said installing step may comprise inserting distal end 135 of obturator131, covered by sleeve 181, through the urethra and into the bladder andthen removing obturator 131, whereby an access path extending across theurethra and into the bladder may be created (see FIG. 108(a)). Method1771 may then continue with a step 1771-2 of inserting a distal end of adelivery device through the access device and into the anatomicalstructure of a patient. This may be done by inserting distal end 1647 ofdelivery device 15 through the remaining installed portion of accessdevice 13 and into the bladder of the patient (see FIG. 108(b)). (Priorto insertion of delivery device 15 into access device 13,pressure-attenuating device 17 may be loaded into delivery device 15 inthe manner discussed above.)

Method 1771 may then continue with a step 1771-3 of inflatingpressure-attenuating device 17 (see FIG. 108(c)). Said inflating stepmay be effected by fully depressing piston 1679 to dispense first fluidmedium 1677 from first syringe 1671 (FIG. 94) into pressure-attenuatingdevice 17 and then by fully depressing piston 1697 to dispense secondfluid medium 1695 (FIG. 95) from second syringe 1691 intopressure-attenuating device 17. (It may be preferred to dispense firstfluid medium 1677 into device 17 before dispensing second fluid medium1695 into device 17 where first fluid medium 1677 is a liquid and secondfluid medium 1695 is a gas since a gas may be useful in flushing aliquid from delivery device 15 into device 17; however, such inflationmay alternatively be achieved by dispensing second fluid medium 1695before first fluid medium 1677 or by simultaneously dispensing firstfluid medium 1677 and second fluid medium 1695.) Method 1771 may thencontinue with a step 1771-4 of releasing pressure-attenuating device 17from delivery device 15 (see FIG. 108(d)), thereby allowing device 17 tofloat freely in the bladder or other anatomical structure. Saidreleasing step may be affected by deactivating safety 1591 and then bysqueezing trigger 1541, thereby causing push-off member 1521 to slidedistally until push-off member 1521 pushes device 17 off of distal end1477 of inflation tube 1471. Method 1771 may then proceed with a step1771-5 of withdrawing the delivery device from the access device. Thismay be done by withdrawing delivery device 15 from the remaininginstalled portion of access device 13 while holding the remaininginstalled portion of access device 13 stationary in the patient. (Accessdevice 13 may thereafter be removed from the patient or may remain inthe patient to provide a conduit through which observational, removal,or other devices may be inserted.)

Some of the advantageous features of using delivery device 15 to deliverpressure-attenuating device 17 are that, due to the orientation andplacement of window 1651, there is a controlled deployment ofpressure-attenuating device 17 away from the trigone of the patient anddevice 17 is kept away from the walls of the bladder while beinginflated, such contact with the walls of the bladder possibly impedingthe opening of valve 1713 to inflate device 17.

Referring back now to FIGS. 81(a) and 82(b), to assist an operator inproperly using delivery device 15, one or both housing halves 1403-1 and1403-2 may be imprinted with certain markings, indicating certain stepsin the delivery sequence. For example, each of housing halves 1403-1 and1403-2 may be imprinted with the following markings: marking 1781-1comprising the number “1” and the text “Inject AirLoc” positionedproximate to opening 1417; marking 1781-2 comprising the number “2” andthe text “Inject Air” positioned proximate to opening 1413; marking1781-3 comprising the number “3” and the text “Release Balloon”positioned proximate to trigger 1541; and marking 1781-4 comprising thenumber “4” and the text “Hold Sheath Remove Tool” positioned proximateto opening 1419. As can be appreciated, markings 1781-1 through 1781-4convey that syringe 1671 is to be emptied, followed by the emptying ofsyringe 1691, followed by the squeezing of trigger 1541, and followed bythe removal of delivery device 15 from the remaining installed portionof access device 13. It is also to be noted that markings 1781-1 and1781-4 can be positioned on housing halves 1403-1 and 1403-2 proximateto the related portions of delivery device 15, thereby reinforcing theconnection between the step to be taken and the related physicalstructure of delivery device 15.

Removal

A removal device may be inserted through the passageway created by anaccess device. The removal device may be used to capture, to deflateand/or to remove the pressure-attenuating device. The removal device mayalso be used to view the inside of the anatomical structure, as well asthe pressure-attenuating device. This viewing may be done during all orpart of the capturing, deflating, and/or removing thepressure-attenuating device.

Certain additional embodiments of a removal device are described in U.S.Patent Application Publication No. 2010/0222802, incorporated byreference herein. See for example: FIGS. 19A-22B, 23H, and 24-29C andthe accompanying discussion, including at paragraphs [0207]-[0274].

Embodiments of a removal device are also provided in U.S. Pat. No.6,976,950, incorporated by reference herein. See for example: FIGS. 12,and 20-23, and the accompanying discussion, including at columns 18-21,and 25-26.

Referring now to FIGS. 109(a) through 109(d), removal device 19according to certain embodiments is shown. The removal device 19 caninclude a pair of scissor-like handles, first member 1801 and secondmember 1803, that can be used to articulate a pair of jaws 1981 and 1983as will be described below.

First member 1801 may be a unitary structure, preferably made of a hard,medical-grade polymer, polytetrafluoroethylene (PTFE)-coated (TEFLON®)aluminum, or a similarly suitable material. Member 1801 may be shaped tocomprise an elongated arm portion 1805 having a transversely-extendingring portion 1807 disposed at one end thereof and having alongitudinally-extending, generally cylindrical portion 1809 disposed atthe opposite end thereof. Ring portion 1807 may be appropriatelydimensioned to receive a thumb of a user. Cylindrical portion 1809 maybe shaped to include a bore 1811 extending longitudinally all the wayfrom a proximal end 1813 to a distal end 1815 and may also be shaped toinclude a cavity 1817 extending longitudinally for a portion of thedistance, but not entirely, from distal end 1815 towards proximal end1813. Bore 1811 may be of comparatively greater diameter and cavity 1817may be of comparatively lesser diameter.

Second member 1803 may be a unitary structure, preferably made of ahard, medical-grade polymer, polytetrafluoroethylene (PTFE)-coated(TEFLON®) aluminum, or a similarly suitable material. Member 1803 may beshaped to comprise an elongated arm portion 1821 having both atransversely-extending ring portion 1823 and a finger rest 1824 disposedat one end thereof and having a longitudinally-extending, generallycylindrical portion 1825 disposed at the opposite end thereof. Ringportion 1823 may be appropriately dimensioned to receive a finger of auser, such as a forefinger, and finger rest 1824 may be appropriatelydimensioned to receive a finger of a user, such as the middle finger.Cylindrical portion 1825 may be shaped to include a bore 1827 ofcomparatively greater diameter extending longitudinally all the way froma proximal end 1829 to a distal end 1831 and a bore 1833 ofcomparatively lesser diameter extending longitudinally all the way fromproximal end 1829 to distal end 1831. Bore 1827 and bore 1833 may havetheir axes generally aligned with bore 1811 and cavity 1817,respectively.

First member 1801 may be coupled to second member 1803 for pivotalmovement relative thereto by a pin 1835 inserted through transverseopenings 1837 and 1839 in first member 1801 and second member 1803,respectively. Pin 1835 may be held in openings 1837 and 1839 by havingan end 1840 received within a cap 1841. In the above manner, firstmember 1801 may be regarded as a movable member pivotally mounted aboutpin 1835, and second member 1803 may be regarded as a stationary member.

Removal device 19 may further comprise a scope connector 1851. Connector1851, which is also shown separately in FIG. 110, may be a unitarystructure, preferably made of a medical-grade stainless steel or asimilarly suitable material. Connector 1851 may be a generally tubularmember comprising a generally circular side wall 1853 defining aproximal end 1855, a distal end 1857, and a longitudinal channel 1859extending all the way from proximal end 1855 to distal end 1857.Longitudinal channel 1859 may include a proximal portion 1859-1 ofcomparatively greater diameter, a distal portion 1859-2 of comparativelylesser diameter, and an intermediate portion 1859-3 intermediate indiameter to proximal portion 1859-1 and distal portion 1859-2.

Removal device 19 may further comprise a ring 1861. Ring 1861, which isalso shown separately in FIG. 111, may be a unitary structure,preferably made of a medical-grade stainless steel or a similarlysuitable material. Ring 1861, which may be fixedly coupled to member1803, may be a generally tubular member comprising a generally circularside wall 1863 defining a proximal end 1865, a distal end 1867, and apair of longitudinal bores 1869 and 1871, each of bores 1869 and 1871extending all the way from proximal end 1865 to distal end 1867. Bore1869 may be generally aligned with and comparable in diameter to bore1827 of member 1803. Bore 1871 may be generally aligned with bore 1833of member 1803 and may include a proximal portion 1871-1 ofcomparatively lesser diameter and a distal portion 1871-2 ofcomparatively greater diameter. Proximal portion 1871-1 may becomparable in diameter to bore 1833 of member 1803.

Removal device 19 may further comprise a scope guide 1881. Guide 1881,which is also shown separately in FIG. 112, may be a unitary structure,preferably made of a medical-grade stainless steel or a similarlysuitable material. Guide 1881 may be a generally tubular membercomprising a generally circular side wall 1883 defining a proximal end1885, a distal end 1887, and a bore 1889, bore 1889 extending all theway from proximal end 1885 to distal end 1887. Proximal end 1885 ofguide 1881 may be fixedly mounted within distal portion 1859-2 of scopeconnector 1851, with the remainder of guide 1881 extending distallythrough bore 1811 of member 1801, through bore 1827 of member 1803, andthrough bore 1869 of ring 1861. The length of guide 1881 passing throughbore 1811 of first member 1801 may be slidable relative to first member1801 whereas the lengths of guide 1881 passing through bore 1827 ofmember 1803 and through bore 1869 of ring 1861 may be fixed relative tomember 1803 and ring 1861, respectively.

Removal device 19 may further comprise a cystoscope 1891. Cystoscope1891, which is also shown separately in FIG. 113, may be a wide anglecystoscope. According to one embodiment, cystoscope 1891 may have afield of view of approximately 30-150 degrees, preferably approximately90-135 degrees, more preferably approximately 105-135 degrees, and morepreferably approximately 115 degrees. According to another embodiment,cystoscope 1891 may have a field of view of approximately 180 degrees.Cystoscope 1891 may comprise an eyepiece portion 1893 and a barrelportion 1895. Eyepiece portion 1893 may comprise a distal end 1897securely mountable within channel 1859 of connector 1851, and barrelportion 1895 may be appropriately dimensioned to extend distally fromconnector 1851 through member 1801, through member 1803, and throughring 1861 and to terminate proximate to the distal end 1887 of guide1881. In this manner, cystoscope 1891 may be fixed relative to guide1881.

Removal device 19 may further comprise a support 1901 (FIGS.109(a)-109(b)). Support 1901, which is also shown separately in FIG.114, may be a unitary structure, preferably made of a medical-gradestainless steel or a similarly suitable material. Support 1901 may be agenerally tubular member comprising a generally circular side wall 1903defining a proximal end 1905, a distal end 1907, and a bore 1909, bore1909 extending all the way from proximal end 1905 to distal end 1907.Proximal end 1905 of support 1901 may be fixedly mounted within distalportion 1871-2 of ring 1861.

Removal device 19 may further comprise a bracket 1921 (FIGS.109(a)-109(b)). Bracket 1921, which is also shown separately in FIG.115, may be a unitary structure, preferably made of a medical-gradestainless steel or a similarly suitable material. Bracket 1921 may beshaped to include a proximal portion 1923 and a distal portion 1925.Proximal portion 1923 may be tubular and may be shaped to include alongitudinal channel 1927. Distal end 1907 of support 1901 may befixedly mounted within channel 1927 of bracket 1921. Distal portion 1925of bracket 1921 may be bifurcated and may include a top member 1929, abottom member 1931, and a connecting member 1932, top member 1929 andbottom member 1931 being spaced apart and generally parallel to oneanother. Top member 1929 may include a transverse opening 1933.Connecting member 1932 may have a bore 1934 aligned with channel 1927.

Removal device 19 may further comprise a rod 1941 (FIG. 109(b)). Rod1941, which is also shown separately in FIG. 116, may be a unitarystructure, preferably made of a medical-grade stainless steel or asimilarly suitable material. Rod 1941 may be a solid, rigid membershaped to include a proximal end 1943 and a distal end 1945. Rod 1941may be appropriately dimensioned to be slidably mounted within support1901, with proximal end 1943 being fixedly mounted within cavity 1817 ofmember 1801 and with distal end 1945 being adapted to slide back andforth through a distal end 1934-1 of bore 1934.

Removal device 19 may further comprise a connector 1951 (FIG. 109(b)).Connector 1951, which is also shown separately in FIG. 117, may be aunitary structure, preferably made of a medical-grade stainless steel ora similarly suitable material. Connector 1951 may be shaped to include aproximal portion 1953 and a distal portion 1955. Proximal portion 1953may be tubular and may be shaped to include a channel 1954 extendinglongitudinally a portion of the way from a proximal end 1953-1 towards adistal end 1953-2. Distal end 1945 of rod 1941 may be fixedly mountedwithin channel 1954 of connector 1951, and proximal portion 1953 ofconnector 1951 may be appropriately dimensioned to slide back and forthwithin bracket 1921. Distal portion 1955 of connector 1951 may begenerally flat and elongated and may be disposed in the space betweentop member 1929 and bottom member 1931 of bracket 1921. Distal portion1955 of connector 1951 may be shaped to include a transverse opening1957.

Removal device 19 may further comprise a pair of linking arms 1961 and1963 (FIGS. 109(b)-109(d)). Arm 1961, which is also shown separately inFIG. 118, may be a unitary structure, preferably made of a medical-gradestainless steel or a similarly suitable material. Arm 1961 may be anelongated flat member shaped to include a first transverse opening 1965proximate to a proximal end 1961-1 of arm 1961 and a second transverseopening 1967 proximate to a distal end 1961-2 of arm 1961. A pivot pin1969 may be received within opening 1965 of arm 1961, as well as withinopening 1957 of connector 1951, so as to pivotally couple arm 1961 toconnector 1951. Arm 1963, which is also shown separately in FIG. 119,may be a unitary structure, preferably made of a medical-grade stainlesssteel or a similarly suitable material. Arm 1963 may be an elongatedflat member shaped to include a first transverse opening 1971 proximateto a proximal end 1963-1 of arm 1963 and a second transverse opening1973 proximate to a distal end 1963-2 of arm 1963. Pivot pin 1969 mayadditionally be received within opening 1971 of arm 1963 so as topivotally couple arm 1963 both to arm 1961 and to connector 1951.

Removal device 19 may further comprise a pair of jaws 1981 and 1983(FIGS. 109(a)-109(d)). The jaws can include corresponding teeth 1997,2017 which can be used to grip or secure an implant. The jaws may alsoinclude one or more surface damaging or compromising structures. Forexample, the surface damaging structure 2003, 2023 can be a needle,knife, sharpened tooth, etc. In some embodiments, the surface damagingstructure can be a cannulated needle that can also serve to allow themedia within in the implant to escape or otherwise be removed. In someembodiments, having the opening in the needle extend the entire lengthof the exposed needle structure permits the balloon to continue todeflate even when the needle has penetrated completely through theballoon. Additionally, the orientation of the sharp edge towards thedistal end of the grasper has the advantage of preventing lacerating theballoon film during the tensile removal of the deflated or partiallydeflated balloon thru the sheath. Additionally, the proximity of theneedle relative to adjacent teeth can improve the function of theremoval system. Specifically, if the space between the tip of the needleand the tip of an adjacent tooth is between 0.05 and 10 times thedifference in height between the tip of the needle and the tip of theadjacent tooth. This distance prevents the balloon from “tenting” overthe needle and adjacent teeth without needle penetration of the balloon.An example of a larger distance between the tip of the needle and thetip of the adjacent tooth is shown in FIG. 120(e). Needle 2513-3 istaller than adjacent tooth 1997. The distance between the tip of thetooth 1997 and needle 2513-1 or 2513-3 is equal to or greater than thedifference in distance between the height of needle 2513-1 or 2513-3 andthe height of the adjacent tooth.

Jaw 1981, which is also shown separately in FIGS. 120(a) through 120(d),may comprise an elongated member 1985 (which may be, for example,approximately 1.55-2.5 inches in length), preferably made of amedical-grade stainless steel or a similarly suitable material. Member1985 may be shaped to include a proximal portion 1987 and a distalportion 1989. Proximal portion 1987, which may comprise a generally flatand arcuate arm, may be shaped to include a first transverse opening1991 proximate to a proximal end 1987-1 of proximal portion 1987 and asecond transverse opening 1993 spaced distally a short distance fromfirst transverse opening 1991. A pivot pin 1995 may be received withinopening 1991 of proximal portion 1987, as well as within opening 1967 ofarm 1961, so as to pivotally couple jaw 1981 to arm 1961. A pivot pin1996 may be received within opening 1993 of proximal portion 1987, aswell as within opening 1933 of bracket 1921, so as to pivotally couplejaw 1981 to bracket 1921. Distal portion 1989 of member 1985 may beshaped to include a row of teeth 1997 facing towards jaw 1983, the rowof teeth 1997 extending proximally from approximately the distal end ofdistal portion 1989. Each tooth 1997 may extend substantially across thewidth of distal portion 1989 and may have a height of, for example,approximately 1-10 mm, preferably approximately 5 mm. Each tooth 1997may have a dulled peak 1997-1 that has a radius of, for example,0.001-0.250 inch, preferably 0.005-0.050 inch, more preferably0.010-0.25 inch. A first transverse opening 1999 may be provided indistal portion 1989 amongst teeth 1997, and a second transverse opening2001 may be provided in distal portion 1989 amongst teeth 1997, firstand second transverse openings 1999 and 2001 being spaced apart from oneanother by a short distance. A cannulated needle 2003 may be fixedlymounted in transverse opening 1999, needle 2003 having a sharpened end2003-1 facing towards jaw 1983. Preferably, needle 2003 has a heightthat exceeds the height of teeth 1997 so that sharpened end 2003-1extends beyond dulled peaks 1997-1. Needle 2003 may have an innerdiameter of, for example, approximately 0.0005-0.500 inch, preferablyapproximately 0.005-0.250 inch, more preferably approximately0.010-0.050 inch, and may have an outer diameter of, for example,approximately 0.001-0.750 inch, preferably approximately 0.010-0.300inch, more preferably approximately 0.015-0.075 inch.

Jaw 1983, which is also shown separately in FIGS. 121(a) through 121(d),may comprise an elongated member 2005 (which may be, for example,approximately 1.55-2.5 inches in length), preferably made of amedical-grade stainless steel or a similarly suitable material. Member2005 may be shaped to include a proximal portion 2007 and a distalportion 2009. Proximal portion 2007, which may comprise a generally flatand arcuate arm, may be shaped to include a first transverse opening2011 proximate to a proximal end 2007-1 of proximal portion 2007 and asecond transverse opening 2013 spaced distally a short distance fromfirst transverse opening 2011. A pivot pin 2015 may be received withinopening 2011 of proximal portion 2007, as well as within opening 1973 ofarm 1963, so as to pivotally couple jaw 1983 to arm 1963. Pivot pin 1996may be received within opening 2013 of proximal portion 2007, as well aswithin opening 1933 of bracket 1921, so as to pivotally couple jaw 1983to bracket 1921. In this manner, proximal movement of rod 1941, whichmay be caused by pivotal movement of ring portion 1807 of member 1801towards ring portion 1823 of member 1803, may cause arms 1961 and 1963to pivot towards each other which, in turn, may cause jaws 1981 and 1983to pivot towards each other. On the other hand, distal movement of rod1941, which may be caused by pivotal movement of ring portion 1807 ofmember 1801 away from ring portion 1823 of member 1803, may cause arms1961 and 1963 to pivot away from one another which, in turn, may causejaws 1981 and 1983 to pivot away from one another. Jaws 1981 and 1983may open to an angle of, for example, approximately 20-150 degrees.

Distal portion 2009 of member 2005 may be shaped to include a row ofteeth 2017 facing towards jaw 1981. The row of teeth 2017 may bestaggered relative to teeth 1997 so that the peaks 1997-1 of teeth 1997may be aligned with the spaces between teeth 2017 when jaws 1981 and1983 are closed and so that the peaks 2017-1 of teeth 2017 may bealigned with the spaces between teeth 1997 when jaws 1981 and 1983 areclosed. Each tooth 2017 may extend substantially across the width ofdistal portion 2009 and may be shaped and dimensioned similarly to eachof teeth 1997. A first transverse opening 2019 may be provided in distalportion 2009 amongst teeth 2017, and a second transverse opening 2021may be provided in distal portion 2009 amongst teeth 2017. Opening 2019may be appropriately positioned and appropriately dimensioned to receivecannulated needle 2003 of jaw 1981 when jaws 1981 and 1983 are closed.(By receiving the sharpened end 2003-1 of needle 2003, opening 2019facilitates and promotes full closure of jaws 1981 and 1983 around aninflated device 17, as opposed to having needle 2003 be deflected fromthe compressed and inflated device 17.) Opening 2019 may have an innerdiameter of, for example, approximately 0.002-0.100 inch, preferably0.010-0.300 inch, more preferably 0.015-0.100 inch. Opening 2021 may bealigned with opening 2001 of jaw 1981 when jaws 1981 and 1983 areclosed, and a cannulated needle 2023 may be fixedly mounted in opening2021 so as to be receivable within opening 2001 of jaw 1981 when jaws1981 and 1983 are closed. Cannulated needle 2023 may have a sharpenedend 2023-1 facing towards jaw 1981, and needle 2023 and opening 2001 maybe dimensioned similarly to needle 2003 and opening 2019, respectively.

Preferably, teeth 1997 and 2017 are dimensioned appropriately so that,when jaws 1981 and 1983 are closed, a small gap 2018 (seen best in FIG.109(d)) is left between the respective rows of teeth 1997 and 2017 thatenables device 17 to be trapped between teeth 1997 and 2017 whileminimizing any tearing of device 17 by teeth 1997 and 2017. In thismanner, device 17 may be securely held or gripped between teeth 1997 and2017 while cannulated needles 2003 and 2023 puncture device 17.Moreover, because needles 2003 and 2023 are cannulated, the fluidcontents of device 17 may be quickly evacuated from device 17 throughneedles 2003 and 2023 without having needles 2003 and 2023 plug the samepuncture holes they create.

It is to be understood that, although cannulated needles 2003 and 2023are described herein as being used to puncture device 17, otherpuncturing devices, such as, but not limited to, blades, scissors, pins,hooks, or the like, may alternatively or additionally be used.

In addition, it is to be understood that, although cannulated needles2003 and 2023 are described herein as being oriented generallyperpendicular to members 1985 and 2005, respectively, cannulated needles2003 and 2023 need not be so oriented and may be oriented, for example,so that sharpened ends 2003-1 and 2023-1 are angled towards proximalportions 1987 and 2007, respectively.

Additionally, it is to be understood that, although both jaw 1981 andjaw 1983 are described herein as being movable, one could make one ofjaws 1981 and 1983 stationary and the other of jaws 1981 and 1983movable.

Referring now to FIG. 122, there is shown a flowchart, schematicallydepicting one possible method 2051 of using removal device 19 to removean implanted pressure-attenuating device 17 from an anatomical structureof a patient, such as a bladder. Method 2051 may begin with a step2051-1 of installing an access device in a patient in any of the mannersdiscussed above. Where, for example, access device 13 is used to providetransurethral access to the bladder, said installing step may compriseinserting distal end 135 of obturator 131, which may be covered bysleeve 181, into the urethra, advancing obturator 131 and sheath 61through the urethra and into the bladder, and then removing obturator131, whereby an access path extending across the urethra and into thebladder may be created (see FIG. 123(a)). Method 2051 may then continuewith a step 2051-2 of inserting the distal end of a removal devicethrough the access device and into the anatomical structure of thepatient. This can be done by inserting the distal end of removal device19 through the remaining installed portion of access device 13 and intothe bladder of the patient (see FIG. 123(b)). (In order to permitinsertion of removal device 19 into access device 13, one may use onehand to pivot ring portion 1807 of member 1801 towards ring portion 1823of member 1803 until jaws 1981 and 1983 close. After jaws 1981 and 1983have been inserted completely through access device 13, jaws 1981 and1983 may then be opened by pivoting ring portion 1807 away from ringportion 1823. Proper placement of the distal end of device 19 within thebladder may be confirmed by observation with scope 1891.)

Where the method 2051 is performed in the bladder, or other fluid filledstructure, the method may then continue with a step 2051-3 of emptyingthe structure of liquid, such as through stopcock valve 287, until theinflated device comes into alignment with removal device. For example,urine can be removed from the bladder until the device 17 is alignedwith opened jaws 1981 and 1983 as observed through scope 1891 (see FIG.123(c)). Method 2051 may then continue with a step 2051-4 of engagingthe inflated device with the removal device. This may also includedeflating the inflated device. For example, the jaws 1981 and 1983 canclose around device 17, causing device 17 to deflate over the nextseveral seconds (see FIG. 123(d)). Method 2051 may then conclude with astep 2051-5 of withdrawing removal device, together with the deflatedpressure-attenuating device from the anatomical structure through theaccess device. The implanted device 17 may be held between jaws 1981 and1983 and may be removed through the remaining installed portion ofaccess device 13 while the remaining installed portion of access device13 is held stationary in the patient. If, for some reason, device 17 hasnot deflated completely as it is being withdrawn from the patient, thedistal end 64 of sheath 61 may advantageously serve as a fulcrum to helpto compress device 17 sufficiently for its facile withdrawal from thepatient. (Access device 13 may thereafter be removed from the patient ormay remain in the patient to provide a conduit through whichobservational, removal, or other devices may be inserted.)

Alternative embodiments to sheath 61 are shown in FIGS. 121 and 122 andare represented generally by reference numerals 2071 and 2081,respectively. Sheaths 2071 and 2081 may be similar in most respects tosheath 61, sheaths 2071 and 2081 differing principally from sheath 61 inthat sheaths 2071 and 2081 may include distal ends 2073 and 2083,respectively. Distal ends 2073 and 2083 may be advantageous inincreasing the contact surface area during removal of device 17 and inforcing device 17 in a certain direction during removal.

As can readily be appreciated, although removal device 19 is discussedabove as being used for observation and removal of an implanted device17, removal device 19 could alternatively be used solely for observationof an implanted device 17, for example, for observation of an implanteddevice 17 immediately after its implantation in a patient to confirmthat device 17 has been implanted properly.

As can be seen from the above discussion, one desirable feature ofremoval device 19 is that removal device 19 may be operated with onehand.

Referring now to FIGS. 126(a), 126(b), and 127, there are shown variousviews of a first alternate embodiment of a removal device, the firstalternate embodiment of the removal device being represented generallyby reference numeral 2101.

Removal device 2101 may be similar in many respects to removal device19. A principal difference between the two devices may be that, whereasremoval device 19 may comprise jaws 1981 and 1983 comprising rows ofteeth 1997 and 2017, respectively, that may be generally triangular inshape in side profile (i.e., when viewed from above device 19), removaldevice 2101 may comprise jaws 2102 and 2104 comprising rows of teeth2103 and 2105, respectively, that may be generally rectangular in shapein side profile.

Removal device 2101 may be used in a similar fashion to removal device19.

Referring now to FIGS. 128(a), 128(b), and 129(a), there are shownvarious views of a second alternate embodiment of a removal device, thefirst alternate embodiment of the removal device being representedgenerally by reference numeral 2151.

Removal device 2151 may be similar in many respects to removal device19. A principal difference between the two devices may be that, whereasremoval device 19 may comprise jaws 1981 and 1983 comprising rows ofteeth 1997 and 2017, respectively, that may be generally triangular inshape in side profile (i.e., when viewed from above device 19), removaldevice 2151 may comprise jaws 2152 and 2154 comprising rows of teeth2153 and 2155, respectively, that may be generally sinusoidal in shapein side profile.

Removal device 2151 may be used in a similar fashion to removal device19.

Referring now to FIGS. 130, 131, and 132(a) through 132(c), there areshown various views of a third alternate embodiment of a removal device,the third alternate embodiment of the removal device being representedgenerally by reference numeral 2201.

Removal device 2201, which may be similar in many respects to removaldevice 19, may comprise a scissors-like handle 2203, a hub 2205, asheath 2206, a cystoscope 2207, a pair of jaws 2209 and 2211, aplurality of cannulated needles 2212-1 through 2212-3, and a wire 2213.

Scissors-like handle 2203, which may be a unitary structure made of ahard, medical-grade polymer or a similarly suitable material, maycomprise a first member 2215, a second member 2217, and a living hingemember 2219. First member 2215 may be shaped to comprise an elongatedarm portion 2221. A transversely-extending ring portion 2223, which maybe appropriately dimensioned to receive, for example, the thumb of auser, may be disposed at one end of arm portion 2221. Second member 2217may be shaped to comprise an elongated arm portion 2227. Atransversely-extending ring portion 2229, which may be appropriatelydimensioned to receive, for example, the forefinger of a user, and afinger rest 2231, which may be appropriately dimensioned to receive, forexample, the middle finger of a user, may be disposed at one end of armportion 2227. The opposite end of arm portion 2227 may be fixedlysecured to sheath 2206. First member 2215 may be coupled to secondmember 2217 for pivotal movement relative thereto by living hinge member2219. In this manner, handle 2203 may be operated much like a pair ofscissors, albeit with first member 2215 being regarded as a movablemember and with second member 2217 being regarded as a stationarymember. It is to be understood, however, that handle 2203 could bemodified so that both first member 2215 and second member 2217 aremovable.

Hub 2205 may be a unitary, tubular structure made of a hard,medical-grade polymer or a similarly suitable material, and sheath 2206may also be a unitary, tubular structure made of a hard, medical-gradepolymer or a similarly suitable material. Hub 2205 and sheath 2206 maybe joined to another by welding, adhesive or other suitable means andmay be arranged to be coaxial with one another, with hub 2205 having acomparatively larger diameter and with sheath 2206 having acomparatively smaller diameter. Each of hub 2205 and sheath 2206 may beappropriately dimensioned to coaxially receive cystoscope 2207. Hub 2205and sheath 2206 may have a combined length such that, when cystoscope2207 is fully inserted into hub 2205 and sheath 2206, a distal end 2235of cystoscope 2207 may extend just distally beyond a distal end 2237 ofsheath 2206.

Sheath 2206 may be circular in transverse cross-section, which may beadvantageous in helping to form a tight seal, for example, with seal 125of access device 13 or, for example, with seal 917 of access device 901.

Cystoscope 2207 may be identical in size, shape, construction, andfunction to cystoscope 1891 of removal device 19.

Jaws 2209 and 2211, which may be similar in certain respects to jaws1981 and 1983 of removal device 19, may be elongated members each madeof a medical-grade polymer or a similarly suitable material. Jaws 2209and 2211 may be pivotally mounted on distal end 2237 of sheath 2206 sothat they may be moved towards and away from each other. Sheath 2206 andjaws 2209 and 2211 may form a unitary structure, with jaw 2209 beingcoupled to sheath 2206 by a living hinge 2241 and with jaw 2211 beingcoupled to sheath 2206 by a living hinge 2243. Articulation of jaws 2209and 2211 may be effected using wire 2213, which may include a first end2251 fixedly coupled to a tab 2253 provided on jaw 2211 and a second end2255 fixedly coupled to a tab 2257 provided on jaw 2209, with anintermediate portion of wire 2213 passing through sheath 2206 beneathcystoscope 2207 and being fixedly coupled to first member 2215 of handle2203. In this manner, as first member 2215 may be pivoted towards secondmember 2217 in a counterclockwise direction indicated by arrow 2218 inFIG. 130, wire 2213 may be moved proximally in tensile fashion, therebycausing jaws 2209 and 2211 to be pivoted towards one another.Conversely, as first member 2215 may be pivoted away from second member2217, wire 2213 may be moved distally, thereby causing jaws 2209 and2211 to be pivoted away from one another. As seen best in FIG. 132(b),when device 2201 is viewed from the top, the left end of wire 2213,namely, end 2251, is secured to the right jaw, namely, jaw 2211, and theright end of wire 2213, namely, end 2255, is secured to the left jaw,namely, jaw 2209. It is believed that such an arrangement isadvantageous in providing increased leverage for closing jaws 2209 and2211.

Jaw 2209 may be shaped to include a post 2260 extending upwardly at adistal end 2263 of jaw 2209, and jaw 2211 may be similarly shaped toinclude a post 2262 extending upwardly at a distal end 2265 of jaw 2211.Posts 2260 and 2262 may be helpful in enabling an operator to visualizethe distal end of device 2201, which may facilitate the capture ofpressure-attenuating device 17 or the like.

Jaw 2209 may be further shaped to include a couplet of teeth 2261-1 and2261-2. Teeth 2261-1 and 2261-2 may be disposed at an intermediatelocation between tab 2257 and post 2260 and may extend generally in thedirection of jaw 2211. A transverse opening 2265, which may serve as arelief hole in the manner to become apparent below, may be provided injaw 2209 between teeth 2261-1 and 2261-2.

Jaw 2211 may be further shaped to include a first couplet of teeth2271-1 and 2271-2 and a second couplet of teeth 2273-1 and 2273-2, allof which may be disposed between tab 2253 and post 2262. Morespecifically, teeth 2271-1 and 2271-2 may be positioned so that, whenjaws 2209 and 2211 are brought together, teeth 2271-1 and 2271-2 may belocated at an intermediate position between tab 2257 and teeth 2261-1and 2261-2, and teeth 2273-1 and 2273-2 may be positioned so that, whenjaws 2209 and 2211 are brought together, teeth 2273-1 and 2273-2 may belocated at an intermediate position between teeth 2261-1 and 2261-2 andpost 2262. A transverse opening 2277 may be provided in jaw 2211 betweenteeth 2271-1 and 2271-2, and a transverse opening 2279 may be providedin jaw 2211 between teeth 2273-1 and 2273-2. Openings 2277 and 2279 mayfunction as relief holes in the manner to become apparent below.

Cannulated needle 2212-1 may be fixedly mounted in a transverse opening2281 provided in jaw 2211 and may be appropriately positioned anddimensioned to be insertable between teeth 2261-1 and 2261-2 when jaws2209 and 2211 are brought together. In a corresponding fashion,cannulated needle 2212-2 may be fixedly mounted in a transverse opening2283 provided in jaw 2209 and may be appropriately positioned anddimensioned to be insertable between teeth 2271-1 and 2271-2 when jaws2209 and 2211 are brought together, and cannulated needle 2212-3 may befixedly mounted in a transverse opening 2285 provided in jaw 2209 andmay be appropriately positioned and dimensioned to be insertable betweenteeth 2273-1 and 2273-2 when jaws 2209 and 2211 are brought together. Itis believed that the present arrangement of teeth and cannulated needlesis advantageous in that the teeth may be particularly well-suited tokeeping taut the pressure-attenuating device 17 or other object that isto be punctured by the cannulated needles.

Cannulated needles 2212-1 through 2212-3 may be beveled at theirrespective free ends, and the bevels may extend to a depth thatapproaches or even exceeds the depths of the teeth on opposing sides ofthe cannulated needle. A bevel that exceeds the depth of the teeth maybe preferred as it may facilitate air loss from the pressure-attenuatingdevice 17 or other object that has been captured and punctured byremoval device 2201.

Removal device 2201 may be used in a similar fashion to removal device19.

It should be understood that the numbers of cannulated needles and teethdisclosed in the present embodiment are merely illustrative and thatsuch numbers may be increased, decreased or otherwise modified. Itshould also be understood that the size, shape and positioning of suchneedles and teeth may also be modified. It should further be understoodthat, although both jaw 2209 and jaw 2211 are described herein as beingmovable, one could make one of jaws 2209 and 2211 stationary and theother of jaws 2209 and 2211 movable.

As alluded to above, handle 2203, hub 2205, sheath 2206, and jaws 2209and 2211 may easily be made at low cost using polymeric materials. Inaddition, needles 2212-1 through 2212-3, and wire 2213 may easily bemade at low cost using metallic materials. Moreover, the assembly ofremoval device 2201 may be achieved economically. Consequently, after asingle use of removal device 2201, cystoscope 2207 may be removed andthe remainder of removal device 2201 may be disposed. Cystoscope 2207may then be sterilized for reuse as part of a new removal device 2201. Abenefit to making the majority of removal device 2201 single-use is thatthere is no depreciation in the performance of the device over time.Alternatively, instead of making cystoscope 2207 removable from hub 2205and sheath 2206 to enable its sterilization and re-use, one couldreplace one or more of the components of cystoscope 2207 withdisposable, single-use components. For example, one could replace therod lens of cystoscope 2207 with an optical fiber or similar materialthat is permanently mounted within hub 2205 and sheath 2206.

Referring now to FIGS. 133(a) through 133(c), 134, 135, 136(a), 136(b),137(a), and 137(b), there are shown various views of a fourth alternateembodiment of a removal device, the fourth alternate embodiment of theremoval device being represented generally by reference numeral 2501.

Removal device 2501 may be similar in many respects to removal device2201. A difference between the two removal devices may be that removaldevice 2501 may be, in its entirety, a disposable single-use device.Removal device 2501 may comprise a cystoscope 2503, a handle assembly2505, a jaw assembly 2507, a sheath 2509, a wire 2511, and a pluralityof cannulated needles 2513-1 through 2513-3.

Cystoscope 2503, which may be made of suitable materials for asingle-use, may comprise an optical fiber 2515, an eyepiece 2517, and alight guide 2519.

Handle assembly 2505, which is also shown separately in FIG. 138, may bea unitary structure shaped to comprise a hub 2521, a first member 2523,and a second member 2525. Hub 2521 may be generally tubular in shape andmay be dimensioned for insertion therethrough of the distal end ofcystoscope 2503. First member 2523 may be shaped to comprise anelongated arm portion 2527. A transversely-extending ring portion 2529,which may be appropriately dimensioned to receive, for example, thethumb of a user, may be disposed at one end of arm portion 2527. Secondmember 2525 may be shaped to comprise an elongated arm portion 2531. Atransversely-extending ring portion 2533, which may be appropriatelydimensioned to receive, for example, the forefinger of a user, and afinger rest 2535, which may be appropriately dimensioned to receive, forexample, the middle finger of a user, may be disposed at one end of armportion 2531. The opposite end of arm portion 2531 may be joined to hub2521. First member 2523 may be coupled to second member 2525 for pivotalmovement relative thereto by living hinge member 2537. In this manner,first member 2523 and second member 2525 may be operated much like apair of scissors, albeit with first member 2523 being regarded as amovable member and with second member 2525 being regarded as astationary member. It is to be understood, however, that handle assembly2505 could be modified so that both first member 2523 and second member2525 are movable.

Jaw assembly 2507, which is also shown separately in FIGS. 139(a)through 139(c), 140(a) and 140(b), may be a unitary structure shaped tocomprise a hub 2541, a first jaw 2543, and a second jaw 2545. Hub 2541may be generally tubular in shape and may be dimensioned to securelyreceive the distal end of sheath 2509. Jaw 2543, which may be identicalto jaw 2209, may be joined to hub 2541 by a living hinge 2547. Jaw 2545,which may be identical to jaw 2211, may be joined to hub 2541 by aliving hinge 2549.

Sheath 2509, which is also shown separately in FIGS. 141(a) and 141(b),may be identical to sheath 2206 and may be shaped to include a firstlongitudinal cavity 2561 and a second longitudinal cavity 2563. Firstlongitudinal cavity 2561 may be appropriately dimensioned to receive,for example, optical fiber 2515 of cystoscope 2503. Second longitudinalcavity 2563 may be appropriately dimensioned to receive, for example,wire 2511. The outer surface of sheath 2509 is circumferential, allowingfor sealing around the sheath when the removal tool is placed in anaccess device such as 13 and 1291 described herein. The circumferentialsurface of sheath 2509 is advantageous compared to the outer surface of1881 and 1901 in removal device 19 described herein. The gap between1881 and 1901 permits leakage around the valves such as 125 and 91described herein.

Wire 2511, which is also shown separately in FIGS. 142(a), 142(b), 143,and 144, may be a unitary structure shaped to include a first leg 2571and a second leg 2573. The proximal ends of first leg 2571 and secondleg 2573 may jointly form a loop 2575, which may be secured to firstmember 2523 of handle assembly 2505. The distal end of first leg 2571may form a hook 2577, which may be secured to second jaw 2545, and thedistal end of second leg 2573 may form a hook 2579, which may be securedto first jaw 2543.

Cannulated needle 2513-1, which may be identical cannulated to needles2513-2 and 2513-3, may be a unitary structure having the shape shown inFIGS. 145(a) and 145(b).

Additional alternate embodiments to removal device 19 may comprise, inaddition to or instead of the cannulated needle, a scissor or similarstructure built into jaws 1981 and 1983 to puncture device 17 as teeth1997 and 2017 hold device 17 or a razor blade or scalpel on one jaw anda receiving slot in the other jaw.

With reference now to FIGS. 146-153 an embodiment of an inflatable cellcompression test fixture 2601 is illustrated. The inflatable cell testfixture 2601 comprises a test vessel 2611, piston 2621, a centering disk2625, a heater 2631, a base 2623, a bracket post 2629, and a heaterbracket 2627. Various views of an embodiment of the test vessel 2611 areillustrated in FIGS. 147(a)-(d). Various views of an embodiment of thepiston 2621 are illustrated in FIGS. 148(a)-(d). Various views of anembodiment of centering disk 2625 are illustrated in FIGS. 149(a)-(e).Various views of an embodiment of the base 2623 are illustrated in FIGS.150(a)-(e). Various views of an embodiment of the bracket post 2629 areillustrated in FIGS. 151(a)-(d). Various views of an embodiment of theheater bracket 2627 are illustrated in FIGS. 152(a)-(d).

The inflatable cell compression test fixture 2601 is assembled (base2623, post 2629 and bracket 2627 with fasteners) and loaded onto thebase 2623 of a vertical tensile and compression testing machine, such asan Instron, MTS, Chatillon, etc. Such machines can measure and recordforce and deflection through a data acquisition system. Data can berecorded in some embodiments at a minimum rate of 25 Hz. Distilled watercan be heated and maintained at 37° C.+/−1° C. (98° F.) for the durationof the test. The test can be performed indoors at an ambient roomtemperature of 21° C. (70° F.). In one embodiment the test fixture canhave a load cell rated at 50 lbs, a cross head speed of 2 inches perminute, a minimum data acquisition rate of 25 Hz, and a minimumcrosshead travel distance of 8 inches. The test fixture 2601 can be usedperform burst tests, deflection/deformation tests, and cyclicalcompression tests on a test vessel 2605.

The burst, deformation, and cyclical tests can be used to evaluatevarious inflatable cell materials, configurations, and wall thicknesses.Force and deformation distance can be measured during testing. Withspecific reference to FIG. 153, the test fixture 2601 can be used tosimulate the clinical experience. During testing, the test sample of theinflatable cell (i.e., balloon) 2605 resides in the test vessel 2611.The opening 2606 for the inverted tail portion of the test sample 2605is shown. The test sample 2605 is oriented within the test vessel 2611so that the opening 2606, or a portion of the opening, is not positionedadjacent the test vessel orifice 2612. Preferably, the opening 2606 ispositioned so that the opening 2606 does not contact the orifice 2612,or a portion of thereof, during operation of the test procedure.Preferably, the test sample is oriented similar to configuration in FIG.153, such that the opening 2606 is aligned on a plane that issubstantially perpendicular to the direction of the force applied by thepiston 2621. The test vessel has a substantially hemispherical-shapedportion with a first diameter 2613, in this embodiment the firstdiameter is 1.625 inches. The test vessel 2611 constrains the testsample's deformation in all directions except at the bottom where thereis a circular orifice 2612. The circular orifice 2612 has a diameter2617. In one embodiment the diameter of the orifice is 0.575 inches. Asthe piston 2621 compresses the test sample 2605, only the portion of thetest sample 2605 that aligned with the circular orifice 2612 is able todeform. Deformation is measured by determining the distance the testsample extends through the orifice 2612. The configuration and testingparameters described herein help replicate usage of the test sample 2605in patients. For example, the pressure applied by the piston 2621substantially replicates the pressure applied in the bladder of apatient and the orifice 2612 is substantially the same as the size ofthe bladder neck and urethra. The specific steps for the burst,deformation, and cyclical tests are described below.

The burst test comprises the steps: (a) position the piston 2621 fortesting on the test fixture 2601; (b) orient the test sample 2605, withthe desired section to be tested pointing down, and adhere the testsample 2605 to the underside of the piston 2621; (c) zero the force onthe load cell; (d) lower the test sample 2605 into the test vessel 2611until the test sample 2605 is close to the bottom of the test vessel2611; (e) set the testing speed to 2.0 inches/min and enable the dataacquisition system to record force and deformation. Set the program tocomplete the test if the force drops 95% of the maximum recorded value,which is usually indicative of test sample failure.

The deflection/deformation test comprises the steps: (a) position thepiston 2621 for testing on the test fixture 2601; (b) orient the testsample 2605, with the desired section to be tested pointing down, andadhere the test sample 2605 to the underside of the piston 2621; (c)zero the force on the load cell; (d) lower the test sample 2605 into thetest vessel 2611 until the test sample 2605 is close to the bottom ofthe test vessel 2611; (e) set the cycle program and data acquisitionsystem to record Force and Deflection. Set the following parameters: (i)crosshead speed to 2.0 inches/min; (ii) set point of 4.25 lbs; (iii)peak force dwell time of 0.5 seconds; (iv) 5 cycles. (f) Record themaximum deflection distance on the 3rd cycle.

The cyclical compression test comprises the steps: (a) position thepiston 2621 for testing on the test fixture 2601; (b) orient the testsample 2605, with the desired section to be tested pointing down, andadhere the test sample 2605 to the underside of the piston 2621; (c)zero the force on the load cell; (d) lower the test sample 2605 into thetest vessel 2611 until the test sample 2605 is close to the bottom ofthe test vessel 2611; (e) set the cycle program and data acquisitionsystem to record Force and Deflection. Set the following parameters: (i)crosshead speed to 2.0 inches/min; (ii) set point of 4.25 lbs; (iii)peak force dwell time of 0.5 seconds; (iv) 50 cycles.

Deformation tests determined the distance the inflatable cell deformsthrough the opening 2612 in the test chamber at a force of 4.25 lbs.Burst tests determined the distance the inflatable cell deformed and theforce required for the inflatable cell to burst. The cyclical testdetermined the number of cycles that the inflatable cell survives with aforce of 4.25 lbs applied in cyclic loading. Based on evaluation ofempirical test data with clinical experience the followingcharacteristics of the inflatable cell were determined.

A table illustrating exemplary test data is shown in FIG. 154. Thecolumns are associated with different embodiments of the inflatablecell. The table is divided into three sections, a top section, a middlesection, and a bottom section. The top section provides thecharacteristics of each cell. For each inflatable cell, the material,manufacturing process, cell size, and the wall thickness is provided.The middle section provides the results of the deformation test, bursttest, and cyclical compression test. For the deformation test, theresults of the cell deformation are provided in millimeters. For theburst test, the results of the force at burst are provided in pounds,and the results of the cell deformation (“d at burst”) are provided inmillimeters. For the cyclical compression test, the results indicatewhether the cell was intact (i.e., 100%) at the end of the test. Thebottom section provides pressure and volume characteristics of theinflatable cells at pressures of 30 cmH₂O and 15 cmH₂O. For each cell, abase cell volume, cell volume at pressure (30 cmH₂O and 15 cmH₂O), andpercentage change in volume from base cell volume to cell volume atpressure (30 cmH₂O and 15 cmH₂O) is provided.

In one embodiment, preferably, the inflatable cell has a burst force ofgreater than about 3 pounds, more preferably greater than about 4pounds, more preferably greater than about 4.9 pounds, more preferablygreater than about 6 pounds, more preferably greater than about 7pounds, and more preferably greater than about 8 pounds. In oneembodiment the preferred inflatable cell will deform less than about 20millimeters, more preferably less than about 18 millimeters, morepreferably less than about 15 millimeters, more preferably less thanabout 11 millimeters, more preferably less than about 10 millimeters,more preferably less than about 8 millimeters, and more preferably lessthan about 6 millimeters with an applied pressure of 4.25 pounds thru ahole in the chamber of 0.575 inches.

Preferably, the wall thickness of the inflatable cell is between about0.0003 and about 0.005 inches, and preferably between 0.0009 and 0.0015.In some embodiments the cell wall thickness can be varied based onmaterials and manufacturing processes. In some embodiments the cell wallthickness is not homogenous and can be varied. In some embodiments, thewall thickness can be varied dependent upon geometric configurations ofthe cell. In some geometric configurations the cell can be configured sothat different portions of the cell have different thicknesses andexhibit different properties based on how the cell is configured to beplaced within the patient.

Preferably the inflatable cell is compliant, so that with a change ininternal pressure, the volume of the inflatable cell increases.Preferably, as the inflatable cell experiences a pressure increase fromzero to 15 cmH₂O, the cell volume increases at least 5%, more preferablythe volume increases at least 10%, from the cell volume at zeropressure. Preferably, as the inflatable cell experiences a pressureincrease from zero to 30 cmH₂O, the cell volume increases at least 10%,more preferably the cell volume increases at least 15%, from the cellvolume at zero pressure.

Preferably the inflatable cell also has sufficient structure to maintainits shape and not deform into the bladder neck and urethra, and toprovide a P_(skin) tension to maintain inflatable cell inflation asdescribed in U.S. Patent Application No. 2010/0222802. Preferably, asthe inflatable cell experiences a pressure increase from zero to 15cmH₂O, the cell volume increases no more than 80% and, more preferably,the cell volume increases no more than 50%, from the cell volume at zeropressure. Preferably, as the inflatable cell experiences a pressureincrease from zero to 30 cmH₂O, the cell volume increases no more than80% and, more preferably, the cell volume increases no more than 50%,from the cell volume at zero pressure.

FIGS. 155 through 158 show exemplary test data for embodiments ofinflatable cells on pressure volume charts. Each chart identifies amaterial used for the embodiment of the inflatable cell. The charts showpressure on the vertical axis in units of cmH₂O. Volume is shown on thehorizontal axis in milliliters. The charts help illustrate thecharacteristics of some embodiments of the inflatable cells. Theinflatable cells can provide predictable expansion based on pressure. Insome embodiments the inflatable cells can have a low deviation fromlinearity as a function of pressure and volume. In some embodiments, thedeviation from linearity can be less than 10%, and in some embodimentsless than 5%.

In some embodiments the inflatable cell can be a silicone, manufacturedwith a dip molding process, estane polyurethane, manufactured with ablow molded process or using welded sheets, and pellethane polyurethane,manufactured with a blow molded process.

Embodiments of inflatable cells have been described as having certainproperties and characteristics as described in relation to specific testprocedures. In some embodiments, the cell may be substantiallyhomogeneous such that the entirety of the inflatable cell exhibits theproperties. For example the cell wall thickness can be substantiallyhomogenous over the surface of the cell. In some embodiments the cellwall thickness can vary throughout the cell. In some embodiments, aportion of the inflatable cell that is less than the entirety of thecell can exhibit the properties. For example a portion of the inflatablecell wall could exhibit the characteristics described.

Although this invention has been disclosed in the context of certainpreferred embodiments and examples, it will be understood by thoseskilled in the art that the present invention extends beyond thespecifically disclosed embodiments to other alternative embodimentsand/or uses of the invention and obvious modifications and equivalentsthereof. In addition, while a number of variations of the invention havebeen shown and described in detail, other modifications, which arewithin the scope of this invention, will be readily apparent to those ofskill in the art based upon this disclosure. It is also contemplatedthat various combinations or sub-combinations of the specific featuresand aspects of the embodiments may be made and still fall within thescope of the invention. Accordingly, it should be understood thatvarious features and aspects of the disclosed embodiments can becombined with or substituted for one another in order to form varyingmodes of the disclosed invention. Thus, it is intended that the scope ofthe present invention herein disclosed should not be limited by theparticular disclosed embodiments described above, but should bedetermined only by a fair reading of the claims that follow.

Similarly, this method of disclosure, is not to be interpreted asreflecting an intention that any claim require more features than areexpressly recited in that claim. Rather, as the following claimsreflect, inventive aspects lie in a combination of fewer than allfeatures of any single foregoing disclosed embodiment. Thus, the claimsfollowing the Detailed Description are hereby expressly incorporatedinto this Detailed Description, with each claim standing on its own as aseparate embodiment.

What is claimed is:
 1. A medical device, the medical device comprisingan implantable inflatable cell, the inflatable cell comprising a bulbportion and an inverted tail portion, wherein the bulb portion of theinflatable cell has an increase in wall thickness near the tail portionthat comprises a circumferential increase in balloon thickness, theincrease in wall thickness being configured to increase resistance toreversal of the inversion of the tail portion, and wherein a ratio of amaximum diameter of an external surface of the bulb portion to an innerdiameter of the tail portion is between 6:1 and 20:1.
 2. The medicaldevice of claim 1, wherein a valve is attached to the inner diameter ofthe tail portion.
 3. The medical device of claim 1, wherein theinflatable cell has a wall thickness of between 0.0001 and 0.25 inches,or between 0.0003 and 0.005 inches.
 4. The medical device of claim 1,wherein the inflatable cell is made of one or more of silicone,polyurethane, estane polyurethane, and pelethane polyurethane.
 5. Themedical device of claim 1, wherein the inflatable cell has an initialvolume between 0.1 cc and 500 cc or between 1 cc and 180 cc, or between10 cc and 60 cc, or 18 ml, or 30 ml.
 6. The medical device of claim 1,further comprising an inflation media comprising a gas.
 7. The medicaldevice of claim 6, wherein the inflation media further comprises aliquid.
 8. The medical device of claim 1, wherein the ratio of themaximum diameter of the external surface of the bulb portion to theinner diameter of the tail portion is greater than 8:1 and less than20:1.
 9. A medical device, the medical device comprising an implantableinflatable cell, the inflatable cell when inflated comprising a bulbportion and a tail portion, wherein a ratio of a maximum diameter of anexternal surface of the bulb portion to an inner diameter of the tailportion is between 6:1 and 20:1; wherein the tail portion is an invertedtubular tail portion extending into the bulb portion, the tail portionterminating in an opening, wherein a valve is attached to the innerdiameter of the tail portion, the valve configured to regulate a flow offluid into and out of the inflatable cell, and wherein the bulb portionof the inflatable cell has an increase in wall thickness near the tailportion that comprises a circumferential increase in balloon thickness,the increase in wall thickness being configured to increase resistanceto reversal of the inversion of the tubular tail portion.
 10. Themedical device of claim 9, wherein the circumferential increase inballoon thickness measures more than one times a diameter of the tailportion and the wall thickness of the bulb portion near the tail portionis less than 0.075 inches.
 11. The medical device of claim 10, whereinthe circumferential increase in balloon thickness measures more than twotimes a diameter of the tail portion.
 12. The medical device of claim 9,wherein a wall thickness of the tail portion is at least 1.5 times awall thickness of the bulb portion.
 13. The medical device of claim 9,wherein the bulb portion comprises a retaining feature disposed on thebulb portion opposite of the tail portion.
 14. The medical device ofclaim 9, wherein the bulb portion is devoid of seams on the externalsurface of the bulb portion.
 15. The medical device of claim 9, whereinthe inflatable cell has a wall thickness of between 0.0001 and 0.25inches, or between 0.0003 and 0.005 inches.
 16. The medical device ofclaim 9, wherein the inflatable cell is made of one or more of silicone,polyurethane, estane polyurethane, and pelethane polyurethane.
 17. Themedical device of claim 9, wherein the inflatable cell has an initialvolume between about 0.1 cc and about 500 cc or between about 1 cc andabout 180 cc, or between about 10 cc and about 60 cc, or about 18 ml, orabout 30 ml.
 18. The medical device of claim 9, further comprising aninflation media comprising a gas.
 19. The medical device of claim 18,wherein the inflation media further comprises a liquid.
 20. The medicaldevice of claim 9, wherein the ratio of the maximum diameter of theexternal surface of the bulb portion to the inner diameter of the tailportion is greater than 8:1 and less than 20:1.
 21. A medical device,the medical device comprising an implantable inflatable cell, theinflatable cell comprising a bulb portion and an inverted tail portion,wherein the bulb portion of the inflatable cell has an increase in wallthickness near the tail portion that comprises a circumferentialincrease in balloon wall thickness, the increase in wall thickness beingconfigured to increase resistance to reversal of the inversion of thetail portion, and wherein a ratio of a maximum diameter of an externalsurface of the bulb portion to an inner diameter of the tail portion isbetween 6:1 and 20:1.
 22. The medical device of claim 21, wherein avalve is attached to the inner diameter of the tail portion.
 23. Themedical device of claim 21, wherein the ratio of the maximum diameter ofthe external surface of the bulb portion to the inner diameter of thetail portion is greater than 8:1 and less than 20:1.
 24. Apressure-attenuating device comprising: (a) an inflatable cell, theinflatable cell comprising an opening, wherein the inflatable cell isseamless, wherein the inflatable cell comprises a bulb portion and aninverted tubular tail portion, the inverted tubular tail portionextending into the bulb portion and terminating at the opening, andwherein the bulb portion of the inflatable cell has an increase in wallthickness near the tail portion that comprises a circumferentialincrease in balloon thickness, so as to increase resistance to reversalof the inversion of the tubular tail portion; and (b) a fluid valvemounted in the opening of the inflatable cell.
 25. Thepressure-attenuating device of claim 24, wherein the inflatable cell hasa generally spherical shape when inflated.
 26. The pressure-attenuatingdevice of claim 24, wherein the inflatable cell further comprises anintegral retaining member formed on the bulb portion of the balloon. 27.The pressure-attenuating device of claim 26, wherein an interface of thebulb portion and the inverted tubular tail portion defines an entry porthaving a diameter and wherein, when the inflatable cell is expandedfully, the bulb portion has a diameter that is 6-10 times the diameterof the entry port.
 28. The pressure-attenuating device of claim 24,wherein the fluid valve comprises a proximal portion, an intermediateportion, and a distal portion, the intermediate portion being generallycylindrical in shape, and the distal portion being generally flat. 29.The pressure-attenuating device of claim 28, wherein the intermediateportion is reduced in inner and outer diameter relative to the proximalportion.
 30. The pressure-attenuating device of claim 28 wherein thedistal portion comprises a duckbill valve.
 31. The pressure-attenuatingdevice of claim 24, wherein the fluid valve is formed by two matchingflat sheets of material heat-sealed along a pair of opposing sides.